Headache & Migraine

During posttreament periods, galcanezumab treatment effects in patients with migraine were reduced, but did not return to baseline, a new study found. Adults with episodic migraine were enrolled into EVOLVE-1 and EVOLVE-, which randomized 858 and 915 patients, respectively, to galcanezumab 120 mg, galcanezumab 240 mg, or placebo, administered subcutaneously once monthly for 6 months. After treatment completion or discontinuation, patients entered a 4-month posttreatment period. Researchers found:

• There were 740 patients (EVOLVE-1) and 830 (EVOLVE-2) patients entered into the posttreatment periods.
• About 95% (EVOLVE-1) and 96% (EVOLVE-2) of patients completed their respective trial.
• In both trials, change from pre-randomization baseline in monthly migraine headache days decreased over the posttreatment period.
• During posttreatment periods, 1.6% (EVOLVE-1) and 2.3% (EVOLVE-2) of patients initiated migraine preventive treatments.
• There were no unexpected adverse events after galcanezumab cessation.

Stauffer VL, et al. Effect of galcanezumab following treatment cessation in patients with migraine: Results from 2 randomized phase 3 trials. [Published online ahead of print April 3, 2019]. Headache. doi: 10.1111/head.13508.

During posttreament periods, galcanezumab treatment effects in patients with migraine were reduced, but did not return to baseline, a new study found. Adults with episodic migraine were enrolled into EVOLVE-1 and EVOLVE-, which randomized 858 and 915 patients, respectively, to galcanezumab 120 mg, galcanezumab 240 mg, or placebo, administered subcutaneously once monthly for 6 months. After treatment completion or discontinuation, patients entered a 4-month posttreatment period. Researchers found:

• There were 740 patients (EVOLVE-1) and 830 (EVOLVE-2) patients entered into the posttreatment periods.
• About 95% (EVOLVE-1) and 96% (EVOLVE-2) of patients completed their respective trial.
• In both trials, change from pre-randomization baseline in monthly migraine headache days decreased over the posttreatment period.
• During posttreatment periods, 1.6% (EVOLVE-1) and 2.3% (EVOLVE-2) of patients initiated migraine preventive treatments.
• There were no unexpected adverse events after galcanezumab cessation.

Stauffer VL, et al. Effect of galcanezumab following treatment cessation in patients with migraine: Results from 2 randomized phase 3 trials. [Published online ahead of print April 3, 2019]. Headache. doi: 10.1111/head.13508.

During posttreament periods, galcanezumab treatment effects in patients with migraine were reduced, but did not return to baseline, a new study found. Adults with episodic migraine were enrolled into EVOLVE-1 and EVOLVE-, which randomized 858 and 915 patients, respectively, to galcanezumab 120 mg, galcanezumab 240 mg, or placebo, administered subcutaneously once monthly for 6 months. After treatment completion or discontinuation, patients entered a 4-month posttreatment period. Researchers found:

• There were 740 patients (EVOLVE-1) and 830 (EVOLVE-2) patients entered into the posttreatment periods.
• About 95% (EVOLVE-1) and 96% (EVOLVE-2) of patients completed their respective trial.
• In both trials, change from pre-randomization baseline in monthly migraine headache days decreased over the posttreatment period.
• During posttreatment periods, 1.6% (EVOLVE-1) and 2.3% (EVOLVE-2) of patients initiated migraine preventive treatments.
• There were no unexpected adverse events after galcanezumab cessation.

Stauffer VL, et al. Effect of galcanezumab following treatment cessation in patients with migraine: Results from 2 randomized phase 3 trials. [Published online ahead of print April 3, 2019]. Headache. doi: 10.1111/head.13508.

Health state utilities associated with migraine treatment estimated from a general population sample may be used to represent route of administration and adverse events (AEs) in cost-utility models, a new study found. In time trade-off interviews, patients with migraine and general population participants in the United Kingdom valued health state vignettes based on literature, medication labels, and clinician interviews. All respondents valued migraine health states varying in route of administration. Researchers found:

• A total of 400 participants completed interviews (200 general population, 200 migraine patients).
• In the general population sample, mean utilities of health states without aura were 0.79 with daily oral medication, 0.78 with 1 injection per month, and 0.72 with between 31 and 39 injections once every 3 months.
• The greatest disutilities were for AEs associated with oral medications.

Matza LS, et al. Health state utilities associated with attributes of migraine preventive treatments based on patient and general population preferences. [Published online ahead of print March 28, 2019]. Qual Life Res. doi: 10.1007/s11136-019-02163-3.

Health state utilities associated with migraine treatment estimated from a general population sample may be used to represent route of administration and adverse events (AEs) in cost-utility models, a new study found. In time trade-off interviews, patients with migraine and general population participants in the United Kingdom valued health state vignettes based on literature, medication labels, and clinician interviews. All respondents valued migraine health states varying in route of administration. Researchers found:

• A total of 400 participants completed interviews (200 general population, 200 migraine patients).
• In the general population sample, mean utilities of health states without aura were 0.79 with daily oral medication, 0.78 with 1 injection per month, and 0.72 with between 31 and 39 injections once every 3 months.
• The greatest disutilities were for AEs associated with oral medications.

Matza LS, et al. Health state utilities associated with attributes of migraine preventive treatments based on patient and general population preferences. [Published online ahead of print March 28, 2019]. Qual Life Res. doi: 10.1007/s11136-019-02163-3.

Health state utilities associated with migraine treatment estimated from a general population sample may be used to represent route of administration and adverse events (AEs) in cost-utility models, a new study found. In time trade-off interviews, patients with migraine and general population participants in the United Kingdom valued health state vignettes based on literature, medication labels, and clinician interviews. All respondents valued migraine health states varying in route of administration. Researchers found:

• A total of 400 participants completed interviews (200 general population, 200 migraine patients).
• In the general population sample, mean utilities of health states without aura were 0.79 with daily oral medication, 0.78 with 1 injection per month, and 0.72 with between 31 and 39 injections once every 3 months.
• The greatest disutilities were for AEs associated with oral medications.

Matza LS, et al. Health state utilities associated with attributes of migraine preventive treatments based on patient and general population preferences. [Published online ahead of print March 28, 2019]. Qual Life Res. doi: 10.1007/s11136-019-02163-3.

Persons with migraine had a much higher prevalence of ever attempting suicide than those without migraine, a recent study found. The study, a nationally representative analysis of the 2012 Canadian Community Health Survey – Mental Health, identified the gender-specific prevalence of suicide attempts among those with migraine and examined the factors associated with suicide attempts among migraineurs. Among the details:

• Of 21,744 respondents, 2223 had migraine.
• Those with migraine had a much higher prevalence of ever attempting suicide vs those without migraine (men: 7.5% vs 1.9%; women: 9.3% vs 2.7%).
• Among migraineurs, the odds of suicide attempts were higher among poorer respondents, those in chronic pain and those with a history of childhood adversities, substance dependence and/or mental illness.

Fuller-Thomson E, Hodgins GA. Suicide attempts among those with migraine: Finding from a nationally representative Canadian study. [Published online ahead of print April 4, 2019]. Arch Suicide Res. doi: 10.1080/13811118.2019.1578710.

Persons with migraine had a much higher prevalence of ever attempting suicide than those without migraine, a recent study found. The study, a nationally representative analysis of the 2012 Canadian Community Health Survey – Mental Health, identified the gender-specific prevalence of suicide attempts among those with migraine and examined the factors associated with suicide attempts among migraineurs. Among the details:

• Of 21,744 respondents, 2223 had migraine.
• Those with migraine had a much higher prevalence of ever attempting suicide vs those without migraine (men: 7.5% vs 1.9%; women: 9.3% vs 2.7%).
• Among migraineurs, the odds of suicide attempts were higher among poorer respondents, those in chronic pain and those with a history of childhood adversities, substance dependence and/or mental illness.

Fuller-Thomson E, Hodgins GA. Suicide attempts among those with migraine: Finding from a nationally representative Canadian study. [Published online ahead of print April 4, 2019]. Arch Suicide Res. doi: 10.1080/13811118.2019.1578710.

Persons with migraine had a much higher prevalence of ever attempting suicide than those without migraine, a recent study found. The study, a nationally representative analysis of the 2012 Canadian Community Health Survey – Mental Health, identified the gender-specific prevalence of suicide attempts among those with migraine and examined the factors associated with suicide attempts among migraineurs. Among the details:

• Of 21,744 respondents, 2223 had migraine.
• Those with migraine had a much higher prevalence of ever attempting suicide vs those without migraine (men: 7.5% vs 1.9%; women: 9.3% vs 2.7%).
• Among migraineurs, the odds of suicide attempts were higher among poorer respondents, those in chronic pain and those with a history of childhood adversities, substance dependence and/or mental illness.

Fuller-Thomson E, Hodgins GA. Suicide attempts among those with migraine: Finding from a nationally representative Canadian study. [Published online ahead of print April 4, 2019]. Arch Suicide Res. doi: 10.1080/13811118.2019.1578710.

Pharmacy databases are a valid source for identification of treatment response in migraine, a recent study found. In a clinical cohort, 1913 migraineurs were interviewed using a semi-structured interview to retrieve treatment response data for acute and prophylactic migraine drugs. Researchers assessed whether number or purchases at different thresholds could predict the specificity and sensitivity of treatment response. The found:

• Purchase of drugs was significantly associated with treatment response.
• Specifically, for migraine drugs, it was concluded that 10 purchases of triptans, or 4 purchases of prophylactic drugs, are sufficient to predict a positive treatment response.
• In the Danish pharmacy database, 73% of migraine patients had purchased 10 or more triptans, while 55% to 63% had purchased 1 or more of the 4 prophylactic drugs.

Hansen TF, Chalmer MA, Haspang TM, Kogelman L, Olesen J. Predicting treatment response using pharmacy register in migraine. J Headache Pain. 2019;20(1):31. doi:10.1186/s10194-019-0987-y.

Pharmacy databases are a valid source for identification of treatment response in migraine, a recent study found. In a clinical cohort, 1913 migraineurs were interviewed using a semi-structured interview to retrieve treatment response data for acute and prophylactic migraine drugs. Researchers assessed whether number or purchases at different thresholds could predict the specificity and sensitivity of treatment response. The found:

• Purchase of drugs was significantly associated with treatment response.
• Specifically, for migraine drugs, it was concluded that 10 purchases of triptans, or 4 purchases of prophylactic drugs, are sufficient to predict a positive treatment response.
• In the Danish pharmacy database, 73% of migraine patients had purchased 10 or more triptans, while 55% to 63% had purchased 1 or more of the 4 prophylactic drugs.

Hansen TF, Chalmer MA, Haspang TM, Kogelman L, Olesen J. Predicting treatment response using pharmacy register in migraine. J Headache Pain. 2019;20(1):31. doi:10.1186/s10194-019-0987-y.

Pharmacy databases are a valid source for identification of treatment response in migraine, a recent study found. In a clinical cohort, 1913 migraineurs were interviewed using a semi-structured interview to retrieve treatment response data for acute and prophylactic migraine drugs. Researchers assessed whether number or purchases at different thresholds could predict the specificity and sensitivity of treatment response. The found:

• Purchase of drugs was significantly associated with treatment response.
• Specifically, for migraine drugs, it was concluded that 10 purchases of triptans, or 4 purchases of prophylactic drugs, are sufficient to predict a positive treatment response.
• In the Danish pharmacy database, 73% of migraine patients had purchased 10 or more triptans, while 55% to 63% had purchased 1 or more of the 4 prophylactic drugs.

Hansen TF, Chalmer MA, Haspang TM, Kogelman L, Olesen J. Predicting treatment response using pharmacy register in migraine. J Headache Pain. 2019;20(1):31. doi:10.1186/s10194-019-0987-y.

Adolescents with migraine headaches have shorter sleep duration and wake up earlier compared to those without migraine, a new study found. The study sample included 10,123 adolescents in the National Comorbidity Survey – Adolescent Supplement, a face-to-face survey of adolescents aged 13 to 18 years in the continental United States. The cross-sectional study examined the associations of sleep patterns, symptoms, and disorders with specific headache subtypes in this population. Researchers found:

• No significant difference in bedtime between youth with and without headache was reported.
• Those with any headache, particularly migraine, had significantly more sleep disturbances than those without headache.
• Youth with migraine and aura were more likely to report difficultly maintaining sleep, early morning awakening, daytime fatigue, and persistent insomnia symptoms vs those with migraine without aura.

Lateef T, Witonsky K, He J, Merikangas KR. Headaches and sleep duration problems in US adolescents: Findings from the National Comorbidity Survey – Adolescent Supplement (NCS-A). [Published online ahead of print April 13, 2019]. Cephalalgia. doi:10.1177/0333102419835466.

Adolescents with migraine headaches have shorter sleep duration and wake up earlier compared to those without migraine, a new study found. The study sample included 10,123 adolescents in the National Comorbidity Survey – Adolescent Supplement, a face-to-face survey of adolescents aged 13 to 18 years in the continental United States. The cross-sectional study examined the associations of sleep patterns, symptoms, and disorders with specific headache subtypes in this population. Researchers found:

• No significant difference in bedtime between youth with and without headache was reported.
• Those with any headache, particularly migraine, had significantly more sleep disturbances than those without headache.
• Youth with migraine and aura were more likely to report difficultly maintaining sleep, early morning awakening, daytime fatigue, and persistent insomnia symptoms vs those with migraine without aura.

Lateef T, Witonsky K, He J, Merikangas KR. Headaches and sleep duration problems in US adolescents: Findings from the National Comorbidity Survey – Adolescent Supplement (NCS-A). [Published online ahead of print April 13, 2019]. Cephalalgia. doi:10.1177/0333102419835466.

Adolescents with migraine headaches have shorter sleep duration and wake up earlier compared to those without migraine, a new study found. The study sample included 10,123 adolescents in the National Comorbidity Survey – Adolescent Supplement, a face-to-face survey of adolescents aged 13 to 18 years in the continental United States. The cross-sectional study examined the associations of sleep patterns, symptoms, and disorders with specific headache subtypes in this population. Researchers found:

• No significant difference in bedtime between youth with and without headache was reported.
• Those with any headache, particularly migraine, had significantly more sleep disturbances than those without headache.
• Youth with migraine and aura were more likely to report difficultly maintaining sleep, early morning awakening, daytime fatigue, and persistent insomnia symptoms vs those with migraine without aura.

Lateef T, Witonsky K, He J, Merikangas KR. Headaches and sleep duration problems in US adolescents: Findings from the National Comorbidity Survey – Adolescent Supplement (NCS-A). [Published online ahead of print April 13, 2019]. Cephalalgia. doi:10.1177/0333102419835466.

MILWAUKEE – Exposure to green light therapy may significantly reduce pain in patients with chronic pain conditions, including migraine and fibromyalgia, an expert reported at the scientific meeting of the American Pain Society.

“There’s a subset of patients in every clinic whose pain doesn’t respond to medical therapies,” said Mohab M. Ibrahim, MD, PhD. “I always wonder what could be done with these patients.”

Dr. Ibrahim, who directs the chronic pain clinic at the University of Arizona, Tucson, walked attendees through an experimental process that began with an observation and has led to human clinical trials of green light therapy.

“Despite being a pharmacologist, I’m really interested in nonpharmacologic methods to manage pain,” he said.

Dr. Ibrahim said the idea for green light therapy came to him when he was speaking with his brother, who experiences migraines. His brother said his headaches were alleviated with time outside, in his back yard, or in one of the many parks in the city where he lives.

Knowing that spending time in nature had salutary effects in general, Dr. Ibrahim, an anesthesiologist and pain management specialist, wondered whether exposure to the sort of light found in nature, with blue skies and the green of a tree canopy, could help control pain.

To begin with, Dr. Ibrahim said, “the question was, do different colors have different behavior aspects on animals?”

Dr. Ibrahim and his collaborators exposed rats to light of various wavelengths across the color spectrum, as well as white and infrared light. They found that the rats who were exposed to blue and green light had a significantly longer latency period before withdrawing their hands and feet from a painfully hot stimulus, showing an antinociceptive effect with these wavelengths similar to that seen with analgesic medication.

“At that point, I decided to pursue green light and to forego blue, because blue can change the circadian rhythm,” said Dr. Ibrahim, adding, “Most pain patients have sleep disturbances to begin with, so to compound that issue is probably not a good idea.”

Dr. Ibrahim and his colleagues wanted to determine whether the analgesic effect had to do with rats seeing the green light or just being exposed to the light. Accordingly, the researchers fitted some rats with tiny, specially manufactured, completely opaque contact lenses. As a control, the researchers applied completely clear contact lenses to another group of rats. “I can’t tell you how many times we got bit, but by the end we got pretty good at it,” said Dr. Ibrahim.

Only the rats with clear lenses had prolonged latency in paw withdrawal to a noxious stimulus with green light exposure; for the rats with the blackout contact lenses, the effect was gone, “suggesting that the visual system is essential in mediating this effect,” noted Dr. Ibrahim.

This series of experiments also showed durable effects of green light exposure. In addition, the analgesic effect of green light did not wane over time, and higher “doses” were not required to achieve the same effect (as is the case with opioids, for example) (Pain. 2017 Feb;158[2]:347-60).

Clues to the mechanism of action came when Dr. Ibrahim and his colleagues administered naloxone to green light-exposed rats. “Naloxone reversed the effects of the green light, suggesting that the endogenous opioid system plays a role in this,” he said, adding that enkephalins were increased two- to threefold in the green light-exposed rats’ spinal cords, and astrocyte activation was reduced as well.

Similar experiments using a rat model of neuropathic pain showed a reversal of pain symptoms with green light exposure, offering promise that green light therapy could be effective in alleviating chronic as well as acute pain.

Moving to humans, Dr. Ibrahim enrolled a small group of individuals from his pain clinic who had refractory migraine into a study that exposed them either to white light or to green light. “These are patients who have failed everything…They have come to me, but I have nothing else to offer them,” he said.

The study had a crossover design. Participants in the small study had baseline pain scores of about 8/10, with no significant drop in pain with white light exposure. However, when the white light patients were crossed over to green light exposure, pain scores dropped to about 3/10. “That’s a greater than 50% reduction in the intensity of their migraine.”

Similar effects were seen in patients with fibromyalgia: “It was exactly the same story…When patients with white light exposure were crossed over [to green light], they had significant reductions in pain,” said Dr. Ibrahim.

“Their opioid use also decreased,” said Dr. Ibrahim. Medication use dropped in green light-exposed patients with migraine and fibromyalgia from an aggregate of about 280 morphine milligram equivalents (MME) to about 150 MME by the end of the study. The small size of the pilot study meant that those differences were not statistically significant.

“A multimodal approach to manage chronic pain patients is probably the best approach that we have so far,” said Dr. Ibrahim. An ongoing clinical trial randomizes patients with chronic pain to white light or green light therapy for two hours daily for 10 weeks, tracking pain scores, medication, and quality of life measures.

Future directions, said Dr. Ibrahim, include a study of the efficacy of green light therapy for patients with interstitial cystitis; another study will investigate green light for postoperative pain control. Sleep may also be improved by green light exposure, and Dr. Ibrahim and his colleagues plan to study this as well.

Dr. Ibrahim reported that his research was supported by the National Institutes of Health. He reported that he had no relevant conflicts of interest.

[email protected]

MILWAUKEE – Exposure to green light therapy may significantly reduce pain in patients with chronic pain conditions, including migraine and fibromyalgia, an expert reported at the scientific meeting of the American Pain Society.

“There’s a subset of patients in every clinic whose pain doesn’t respond to medical therapies,” said Mohab M. Ibrahim, MD, PhD. “I always wonder what could be done with these patients.”

Dr. Ibrahim, who directs the chronic pain clinic at the University of Arizona, Tucson, walked attendees through an experimental process that began with an observation and has led to human clinical trials of green light therapy.

“Despite being a pharmacologist, I’m really interested in nonpharmacologic methods to manage pain,” he said.

Dr. Ibrahim said the idea for green light therapy came to him when he was speaking with his brother, who experiences migraines. His brother said his headaches were alleviated with time outside, in his back yard, or in one of the many parks in the city where he lives.

Knowing that spending time in nature had salutary effects in general, Dr. Ibrahim, an anesthesiologist and pain management specialist, wondered whether exposure to the sort of light found in nature, with blue skies and the green of a tree canopy, could help control pain.

To begin with, Dr. Ibrahim said, “the question was, do different colors have different behavior aspects on animals?”

Dr. Ibrahim and his collaborators exposed rats to light of various wavelengths across the color spectrum, as well as white and infrared light. They found that the rats who were exposed to blue and green light had a significantly longer latency period before withdrawing their hands and feet from a painfully hot stimulus, showing an antinociceptive effect with these wavelengths similar to that seen with analgesic medication.

“At that point, I decided to pursue green light and to forego blue, because blue can change the circadian rhythm,” said Dr. Ibrahim, adding, “Most pain patients have sleep disturbances to begin with, so to compound that issue is probably not a good idea.”

Dr. Ibrahim and his colleagues wanted to determine whether the analgesic effect had to do with rats seeing the green light or just being exposed to the light. Accordingly, the researchers fitted some rats with tiny, specially manufactured, completely opaque contact lenses. As a control, the researchers applied completely clear contact lenses to another group of rats. “I can’t tell you how many times we got bit, but by the end we got pretty good at it,” said Dr. Ibrahim.

Only the rats with clear lenses had prolonged latency in paw withdrawal to a noxious stimulus with green light exposure; for the rats with the blackout contact lenses, the effect was gone, “suggesting that the visual system is essential in mediating this effect,” noted Dr. Ibrahim.

This series of experiments also showed durable effects of green light exposure. In addition, the analgesic effect of green light did not wane over time, and higher “doses” were not required to achieve the same effect (as is the case with opioids, for example) (Pain. 2017 Feb;158[2]:347-60).

Clues to the mechanism of action came when Dr. Ibrahim and his colleagues administered naloxone to green light-exposed rats. “Naloxone reversed the effects of the green light, suggesting that the endogenous opioid system plays a role in this,” he said, adding that enkephalins were increased two- to threefold in the green light-exposed rats’ spinal cords, and astrocyte activation was reduced as well.

Similar experiments using a rat model of neuropathic pain showed a reversal of pain symptoms with green light exposure, offering promise that green light therapy could be effective in alleviating chronic as well as acute pain.

Moving to humans, Dr. Ibrahim enrolled a small group of individuals from his pain clinic who had refractory migraine into a study that exposed them either to white light or to green light. “These are patients who have failed everything…They have come to me, but I have nothing else to offer them,” he said.

The study had a crossover design. Participants in the small study had baseline pain scores of about 8/10, with no significant drop in pain with white light exposure. However, when the white light patients were crossed over to green light exposure, pain scores dropped to about 3/10. “That’s a greater than 50% reduction in the intensity of their migraine.”

Similar effects were seen in patients with fibromyalgia: “It was exactly the same story…When patients with white light exposure were crossed over [to green light], they had significant reductions in pain,” said Dr. Ibrahim.

“Their opioid use also decreased,” said Dr. Ibrahim. Medication use dropped in green light-exposed patients with migraine and fibromyalgia from an aggregate of about 280 morphine milligram equivalents (MME) to about 150 MME by the end of the study. The small size of the pilot study meant that those differences were not statistically significant.

“A multimodal approach to manage chronic pain patients is probably the best approach that we have so far,” said Dr. Ibrahim. An ongoing clinical trial randomizes patients with chronic pain to white light or green light therapy for two hours daily for 10 weeks, tracking pain scores, medication, and quality of life measures.

Future directions, said Dr. Ibrahim, include a study of the efficacy of green light therapy for patients with interstitial cystitis; another study will investigate green light for postoperative pain control. Sleep may also be improved by green light exposure, and Dr. Ibrahim and his colleagues plan to study this as well.

Dr. Ibrahim reported that his research was supported by the National Institutes of Health. He reported that he had no relevant conflicts of interest.

[email protected]

MILWAUKEE – Exposure to green light therapy may significantly reduce pain in patients with chronic pain conditions, including migraine and fibromyalgia, an expert reported at the scientific meeting of the American Pain Society.

“There’s a subset of patients in every clinic whose pain doesn’t respond to medical therapies,” said Mohab M. Ibrahim, MD, PhD. “I always wonder what could be done with these patients.”

Dr. Ibrahim, who directs the chronic pain clinic at the University of Arizona, Tucson, walked attendees through an experimental process that began with an observation and has led to human clinical trials of green light therapy.

“Despite being a pharmacologist, I’m really interested in nonpharmacologic methods to manage pain,” he said.

Dr. Ibrahim said the idea for green light therapy came to him when he was speaking with his brother, who experiences migraines. His brother said his headaches were alleviated with time outside, in his back yard, or in one of the many parks in the city where he lives.

Knowing that spending time in nature had salutary effects in general, Dr. Ibrahim, an anesthesiologist and pain management specialist, wondered whether exposure to the sort of light found in nature, with blue skies and the green of a tree canopy, could help control pain.

To begin with, Dr. Ibrahim said, “the question was, do different colors have different behavior aspects on animals?”

Dr. Ibrahim and his collaborators exposed rats to light of various wavelengths across the color spectrum, as well as white and infrared light. They found that the rats who were exposed to blue and green light had a significantly longer latency period before withdrawing their hands and feet from a painfully hot stimulus, showing an antinociceptive effect with these wavelengths similar to that seen with analgesic medication.

“At that point, I decided to pursue green light and to forego blue, because blue can change the circadian rhythm,” said Dr. Ibrahim, adding, “Most pain patients have sleep disturbances to begin with, so to compound that issue is probably not a good idea.”

Dr. Ibrahim and his colleagues wanted to determine whether the analgesic effect had to do with rats seeing the green light or just being exposed to the light. Accordingly, the researchers fitted some rats with tiny, specially manufactured, completely opaque contact lenses. As a control, the researchers applied completely clear contact lenses to another group of rats. “I can’t tell you how many times we got bit, but by the end we got pretty good at it,” said Dr. Ibrahim.

Only the rats with clear lenses had prolonged latency in paw withdrawal to a noxious stimulus with green light exposure; for the rats with the blackout contact lenses, the effect was gone, “suggesting that the visual system is essential in mediating this effect,” noted Dr. Ibrahim.

This series of experiments also showed durable effects of green light exposure. In addition, the analgesic effect of green light did not wane over time, and higher “doses” were not required to achieve the same effect (as is the case with opioids, for example) (Pain. 2017 Feb;158[2]:347-60).

Clues to the mechanism of action came when Dr. Ibrahim and his colleagues administered naloxone to green light-exposed rats. “Naloxone reversed the effects of the green light, suggesting that the endogenous opioid system plays a role in this,” he said, adding that enkephalins were increased two- to threefold in the green light-exposed rats’ spinal cords, and astrocyte activation was reduced as well.

Similar experiments using a rat model of neuropathic pain showed a reversal of pain symptoms with green light exposure, offering promise that green light therapy could be effective in alleviating chronic as well as acute pain.

Moving to humans, Dr. Ibrahim enrolled a small group of individuals from his pain clinic who had refractory migraine into a study that exposed them either to white light or to green light. “These are patients who have failed everything…They have come to me, but I have nothing else to offer them,” he said.

The study had a crossover design. Participants in the small study had baseline pain scores of about 8/10, with no significant drop in pain with white light exposure. However, when the white light patients were crossed over to green light exposure, pain scores dropped to about 3/10. “That’s a greater than 50% reduction in the intensity of their migraine.”

Similar effects were seen in patients with fibromyalgia: “It was exactly the same story…When patients with white light exposure were crossed over [to green light], they had significant reductions in pain,” said Dr. Ibrahim.

“Their opioid use also decreased,” said Dr. Ibrahim. Medication use dropped in green light-exposed patients with migraine and fibromyalgia from an aggregate of about 280 morphine milligram equivalents (MME) to about 150 MME by the end of the study. The small size of the pilot study meant that those differences were not statistically significant.

“A multimodal approach to manage chronic pain patients is probably the best approach that we have so far,” said Dr. Ibrahim. An ongoing clinical trial randomizes patients with chronic pain to white light or green light therapy for two hours daily for 10 weeks, tracking pain scores, medication, and quality of life measures.

Future directions, said Dr. Ibrahim, include a study of the efficacy of green light therapy for patients with interstitial cystitis; another study will investigate green light for postoperative pain control. Sleep may also be improved by green light exposure, and Dr. Ibrahim and his colleagues plan to study this as well.

Dr. Ibrahim reported that his research was supported by the National Institutes of Health. He reported that he had no relevant conflicts of interest.

[email protected]

PHILADELPHIA – An orally dissolving tablet formulation of rimegepant has significant effects on pain relief and functional ability at 60 minutes post dose, according to phase 3 trial results presented at the annual meeting of the American Academy of Neurology. The treatment’s efficacy is sustained for 2-48 hours, researchers reported.

Rimegepant is a small molecule calcitonin gene–related peptide receptor antagonist. A 75-mg oral tablet formulation was effective in phase 3 trials. The present study evaluated a novel, orally dissolving tablet formulation that is intended to speed the drug’s onset. The tablet’s time to peak concentration is 1.50 hours, compared with 1.99 hours for the oral tablet.

Formulation preferences

“People with migraine prefer orally dissolving tablets to oral tablets, mainly for their convenience, onset of action, and ability to be taken without drinking liquids,” said first author Richard B. Lipton, MD, of Albert Einstein College of Medicine, New York, and colleagues.

To assess the formulation’s efficacy and safety, the investigators conducted a double-blind, randomized, placebo-controlled, multicenter trial. Participants were aged at least 18 years and had migraine for at least 1 year. They had 2-8 moderate or severe migraine attacks and fewer than 15 headache days per month during the 3 months before the trial. Their preventive migraine medication doses, if any, had been stable for at least 3 months.

Coprimary efficacy endpoints were pain freedom 2 hours post dose and freedom from the most bothersome symptom at 2 hours post dose. The efficacy analyses included randomized subjects who had a qualifying migraine attack, took the study medication, and provided at least one postbaseline efficacy data point.

The investigators included 1,351 patients in their efficacy analysis – 669 who received rimegepant and 682 who received placebo. About 85% were female, and patients’ mean age was 40.2 years. They averaged 4.6 migraine attacks per month, and their most bothersome symptoms included photophobia (57%), nausea (23.5%), and phonophobia (19.3%). About 14% used preventive treatment.

Within 45 days of randomization, patients treated a migraine attack of moderate to severe intensity and completed an electronic diary predose to 48 hours post dose.

Less use of rescue medication

At 2 hours post dose, patients who received 75 mg rimegepant were more likely than patients who received placebo to achieve pain freedom (21.2% vs. 10.9%) and freedom from the most bothersome symptom (35.1% vs. 26.8%).

Numerical differences in the likelihood of pain relief between group began 15 minutes post dose, and the difference was statistically significant at 60 minutes (36.8% vs. 31.2%).

Various secondary endpoints, including ability to function normally at 2 hours post dose (38.1% vs. 25.8%), sustained pain relief from 2-48 hours (42.2% vs. 25.2%), and use of rescue medications within 24 hours (14.2% vs. 29.2%), also were statistically significant.

In the safety analysis, the most common adverse events were nausea (1.6% in the rimegepant group and 0.4% in the placebo group) and urinary tract infection (1.5% in the rimegepant group and 0.6% in the placebo group). There were no serious adverse events. “Safety and tolerability were similar to placebo,” Dr. Lipton and colleagues said.

Biohaven Pharmaceuticals, the developer of the drug, sponsored the study. Dr. Lipton has received honoraria and research support from Biohaven and holds stock in the company. Coauthors are employees of Biohaven.

[email protected]

PHILADELPHIA – An orally dissolving tablet formulation of rimegepant has significant effects on pain relief and functional ability at 60 minutes post dose, according to phase 3 trial results presented at the annual meeting of the American Academy of Neurology. The treatment’s efficacy is sustained for 2-48 hours, researchers reported.

Rimegepant is a small molecule calcitonin gene–related peptide receptor antagonist. A 75-mg oral tablet formulation was effective in phase 3 trials. The present study evaluated a novel, orally dissolving tablet formulation that is intended to speed the drug’s onset. The tablet’s time to peak concentration is 1.50 hours, compared with 1.99 hours for the oral tablet.

Formulation preferences

“People with migraine prefer orally dissolving tablets to oral tablets, mainly for their convenience, onset of action, and ability to be taken without drinking liquids,” said first author Richard B. Lipton, MD, of Albert Einstein College of Medicine, New York, and colleagues.

To assess the formulation’s efficacy and safety, the investigators conducted a double-blind, randomized, placebo-controlled, multicenter trial. Participants were aged at least 18 years and had migraine for at least 1 year. They had 2-8 moderate or severe migraine attacks and fewer than 15 headache days per month during the 3 months before the trial. Their preventive migraine medication doses, if any, had been stable for at least 3 months.

Coprimary efficacy endpoints were pain freedom 2 hours post dose and freedom from the most bothersome symptom at 2 hours post dose. The efficacy analyses included randomized subjects who had a qualifying migraine attack, took the study medication, and provided at least one postbaseline efficacy data point.

The investigators included 1,351 patients in their efficacy analysis – 669 who received rimegepant and 682 who received placebo. About 85% were female, and patients’ mean age was 40.2 years. They averaged 4.6 migraine attacks per month, and their most bothersome symptoms included photophobia (57%), nausea (23.5%), and phonophobia (19.3%). About 14% used preventive treatment.

Within 45 days of randomization, patients treated a migraine attack of moderate to severe intensity and completed an electronic diary predose to 48 hours post dose.

Less use of rescue medication

At 2 hours post dose, patients who received 75 mg rimegepant were more likely than patients who received placebo to achieve pain freedom (21.2% vs. 10.9%) and freedom from the most bothersome symptom (35.1% vs. 26.8%).

Numerical differences in the likelihood of pain relief between group began 15 minutes post dose, and the difference was statistically significant at 60 minutes (36.8% vs. 31.2%).

Various secondary endpoints, including ability to function normally at 2 hours post dose (38.1% vs. 25.8%), sustained pain relief from 2-48 hours (42.2% vs. 25.2%), and use of rescue medications within 24 hours (14.2% vs. 29.2%), also were statistically significant.

In the safety analysis, the most common adverse events were nausea (1.6% in the rimegepant group and 0.4% in the placebo group) and urinary tract infection (1.5% in the rimegepant group and 0.6% in the placebo group). There were no serious adverse events. “Safety and tolerability were similar to placebo,” Dr. Lipton and colleagues said.

Biohaven Pharmaceuticals, the developer of the drug, sponsored the study. Dr. Lipton has received honoraria and research support from Biohaven and holds stock in the company. Coauthors are employees of Biohaven.

[email protected]

PHILADELPHIA – An orally dissolving tablet formulation of rimegepant has significant effects on pain relief and functional ability at 60 minutes post dose, according to phase 3 trial results presented at the annual meeting of the American Academy of Neurology. The treatment’s efficacy is sustained for 2-48 hours, researchers reported.

Rimegepant is a small molecule calcitonin gene–related peptide receptor antagonist. A 75-mg oral tablet formulation was effective in phase 3 trials. The present study evaluated a novel, orally dissolving tablet formulation that is intended to speed the drug’s onset. The tablet’s time to peak concentration is 1.50 hours, compared with 1.99 hours for the oral tablet.

Formulation preferences

“People with migraine prefer orally dissolving tablets to oral tablets, mainly for their convenience, onset of action, and ability to be taken without drinking liquids,” said first author Richard B. Lipton, MD, of Albert Einstein College of Medicine, New York, and colleagues.

To assess the formulation’s efficacy and safety, the investigators conducted a double-blind, randomized, placebo-controlled, multicenter trial. Participants were aged at least 18 years and had migraine for at least 1 year. They had 2-8 moderate or severe migraine attacks and fewer than 15 headache days per month during the 3 months before the trial. Their preventive migraine medication doses, if any, had been stable for at least 3 months.

Coprimary efficacy endpoints were pain freedom 2 hours post dose and freedom from the most bothersome symptom at 2 hours post dose. The efficacy analyses included randomized subjects who had a qualifying migraine attack, took the study medication, and provided at least one postbaseline efficacy data point.

The investigators included 1,351 patients in their efficacy analysis – 669 who received rimegepant and 682 who received placebo. About 85% were female, and patients’ mean age was 40.2 years. They averaged 4.6 migraine attacks per month, and their most bothersome symptoms included photophobia (57%), nausea (23.5%), and phonophobia (19.3%). About 14% used preventive treatment.

Within 45 days of randomization, patients treated a migraine attack of moderate to severe intensity and completed an electronic diary predose to 48 hours post dose.

Less use of rescue medication

At 2 hours post dose, patients who received 75 mg rimegepant were more likely than patients who received placebo to achieve pain freedom (21.2% vs. 10.9%) and freedom from the most bothersome symptom (35.1% vs. 26.8%).

Numerical differences in the likelihood of pain relief between group began 15 minutes post dose, and the difference was statistically significant at 60 minutes (36.8% vs. 31.2%).

Various secondary endpoints, including ability to function normally at 2 hours post dose (38.1% vs. 25.8%), sustained pain relief from 2-48 hours (42.2% vs. 25.2%), and use of rescue medications within 24 hours (14.2% vs. 29.2%), also were statistically significant.

In the safety analysis, the most common adverse events were nausea (1.6% in the rimegepant group and 0.4% in the placebo group) and urinary tract infection (1.5% in the rimegepant group and 0.6% in the placebo group). There were no serious adverse events. “Safety and tolerability were similar to placebo,” Dr. Lipton and colleagues said.

Biohaven Pharmaceuticals, the developer of the drug, sponsored the study. Dr. Lipton has received honoraria and research support from Biohaven and holds stock in the company. Coauthors are employees of Biohaven.

[email protected]

PHILADELPHIA – At the annual meeting of the American Academy of Neurology, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, sat down with Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth, Hanover, N.H., to discuss in a video some of the new data presented at the meeting regarding the CGRP monoclonal antibodies, the small molecule receptor antagonists (gepants), and what Dr. Tepper described as “a real shift in paradigm and a watershed moment in migraine.”

The three gepants that are farthest along in clinical trials are ubrogepant, rimegepant, and atogepant. “Reassuring data” was presented, Dr. Tepper said, regarding liver toxicity, which has been a concern with earlier generations of the gepants. The Food and Drug Administration had mandated a close look at liver function with the use of these drugs, which are metabolized in the liver, and, to date, no safety signals have emerged.

The three CGRP monoclonal antibodies that are currently on the market are erenumab (Aimovig), fremanezumab (Ajovy), and galcanezumab (Emgality). Data from numerous open-label extension studies were presented. In general, it seems that “the monoclonal antibodies accumulate greater efficacy over time,” Dr. Tepper said. No safety concerns have emerged from 5 years of clinical trial data. With 250,000 patients on these drugs worldwide, that is “very reassuring,” Dr. Tepper said.

New data also show that the majority of patients with chronic migraine who are taking monoclonal antibodies convert from chronic migraine to episodic migraine. Additionally, new data show that use of monoclonal antibodies “dramatically reduce all migraine medication use,” Dr. Tepper said.

[email protected]

PHILADELPHIA – At the annual meeting of the American Academy of Neurology, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, sat down with Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth, Hanover, N.H., to discuss in a video some of the new data presented at the meeting regarding the CGRP monoclonal antibodies, the small molecule receptor antagonists (gepants), and what Dr. Tepper described as “a real shift in paradigm and a watershed moment in migraine.”

The three gepants that are farthest along in clinical trials are ubrogepant, rimegepant, and atogepant. “Reassuring data” was presented, Dr. Tepper said, regarding liver toxicity, which has been a concern with earlier generations of the gepants. The Food and Drug Administration had mandated a close look at liver function with the use of these drugs, which are metabolized in the liver, and, to date, no safety signals have emerged.

The three CGRP monoclonal antibodies that are currently on the market are erenumab (Aimovig), fremanezumab (Ajovy), and galcanezumab (Emgality). Data from numerous open-label extension studies were presented. In general, it seems that “the monoclonal antibodies accumulate greater efficacy over time,” Dr. Tepper said. No safety concerns have emerged from 5 years of clinical trial data. With 250,000 patients on these drugs worldwide, that is “very reassuring,” Dr. Tepper said.

New data also show that the majority of patients with chronic migraine who are taking monoclonal antibodies convert from chronic migraine to episodic migraine. Additionally, new data show that use of monoclonal antibodies “dramatically reduce all migraine medication use,” Dr. Tepper said.

[email protected]

PHILADELPHIA – At the annual meeting of the American Academy of Neurology, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, sat down with Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth, Hanover, N.H., to discuss in a video some of the new data presented at the meeting regarding the CGRP monoclonal antibodies, the small molecule receptor antagonists (gepants), and what Dr. Tepper described as “a real shift in paradigm and a watershed moment in migraine.”

The three gepants that are farthest along in clinical trials are ubrogepant, rimegepant, and atogepant. “Reassuring data” was presented, Dr. Tepper said, regarding liver toxicity, which has been a concern with earlier generations of the gepants. The Food and Drug Administration had mandated a close look at liver function with the use of these drugs, which are metabolized in the liver, and, to date, no safety signals have emerged.

The three CGRP monoclonal antibodies that are currently on the market are erenumab (Aimovig), fremanezumab (Ajovy), and galcanezumab (Emgality). Data from numerous open-label extension studies were presented. In general, it seems that “the monoclonal antibodies accumulate greater efficacy over time,” Dr. Tepper said. No safety concerns have emerged from 5 years of clinical trial data. With 250,000 patients on these drugs worldwide, that is “very reassuring,” Dr. Tepper said.

New data also show that the majority of patients with chronic migraine who are taking monoclonal antibodies convert from chronic migraine to episodic migraine. Additionally, new data show that use of monoclonal antibodies “dramatically reduce all migraine medication use,” Dr. Tepper said.

[email protected]

PHILADELPHIA – Galcanezumab reduces weekly attack frequency in patients with episodic cluster headache, according to study results presented at the annual meeting of the American Academy of Neurology. The treatment has a similar safety profile in this patient population as it has among people with episodic or chronic migraine, said the researchers.

Calcitonin gene-related peptide (CGRP) has an important role in the pathogenesis of cluster headache. Galcanezumab (Emgality)is a humanized monoclonal antibody that binds to CGRP. Eli Lilly & Co. developed the molecule as a treatment for migraine. Cluster headache is characterized by recurrent unilateral headache attacks accompanied by autonomic symptoms. The most common acute treatments for cluster headache are sumatriptan (Imitrex) and high-flow oxygen, but some patients do not respond to these therapies.

David W. Dodick, MD, director of the headache, sports neurology, and concussion programs at Mayo Clinic in Phoenix, and colleagues conducted a trial to evaluate the efficacy and safety of galcanezumab in patients with episodic cluster headache.

After screening, participants underwent a prospective baseline diary phase for 7 consecutive days. The investigators subsequently randomized patients in equal groups to galcanezumab (300 mg subcutaneously) or placebo. Treatment was administered subcutaneously once monthly. The double-blind treatment period lasted for 8 weeks, and a washout period followed. The trial’s primary endpoint was the overall mean change from baseline in weekly cluster headache attack frequency during weeks 1-3, as recorded in patient diaries. The main secondary endpoint was the proportion of patients who had a reduction in weekly cluster headache attack frequency of 50% or more at week 3.

In all, 49 patients were randomized to galcanezumab, and 57 were randomized to placebo. Mean age was 45-47 years. Between 82% and 84% of patients were male. The mean number of weekly cluster headache attacks at baseline was approximately 17.5 in both groups.

During weeks 1-3, the mean change in weekly attack frequency was −8.7 in the galcanezumab group and −5.2 for controls. The difference between groups was statistically significant. The percentage of participants with a reduction in weekly attack frequency of at least 50% at week 3 was 76% for galcanezumab versus 57% for placebo. The between-group differences in these endpoints were statistically significant.

The discontinuation rate was 8% (4 participants) in the galcanezumab group and 21% (12 participants) in the placebo group. Eight participants (14%) in the placebo group discontinued treatment because of lack of efficacy, compared with one participant (2%) in the galcanezumab group. The researchers observed no clinically meaningful differences between treatment groups on tolerability or safety parameters except for a greater incidence of injection-site pain with galcanezumab versus placebo (8.2% vs. 0%).

Eli Lilly and Co. sponsored the study. Dr. Dodick has a consulting relationship with the company.

[email protected]

SOURCE: Bardos JN et al. AAN 2019, Abstract 02.004.

PHILADELPHIA – Galcanezumab reduces weekly attack frequency in patients with episodic cluster headache, according to study results presented at the annual meeting of the American Academy of Neurology. The treatment has a similar safety profile in this patient population as it has among people with episodic or chronic migraine, said the researchers.

Calcitonin gene-related peptide (CGRP) has an important role in the pathogenesis of cluster headache. Galcanezumab (Emgality)is a humanized monoclonal antibody that binds to CGRP. Eli Lilly & Co. developed the molecule as a treatment for migraine. Cluster headache is characterized by recurrent unilateral headache attacks accompanied by autonomic symptoms. The most common acute treatments for cluster headache are sumatriptan (Imitrex) and high-flow oxygen, but some patients do not respond to these therapies.

David W. Dodick, MD, director of the headache, sports neurology, and concussion programs at Mayo Clinic in Phoenix, and colleagues conducted a trial to evaluate the efficacy and safety of galcanezumab in patients with episodic cluster headache.

After screening, participants underwent a prospective baseline diary phase for 7 consecutive days. The investigators subsequently randomized patients in equal groups to galcanezumab (300 mg subcutaneously) or placebo. Treatment was administered subcutaneously once monthly. The double-blind treatment period lasted for 8 weeks, and a washout period followed. The trial’s primary endpoint was the overall mean change from baseline in weekly cluster headache attack frequency during weeks 1-3, as recorded in patient diaries. The main secondary endpoint was the proportion of patients who had a reduction in weekly cluster headache attack frequency of 50% or more at week 3.

In all, 49 patients were randomized to galcanezumab, and 57 were randomized to placebo. Mean age was 45-47 years. Between 82% and 84% of patients were male. The mean number of weekly cluster headache attacks at baseline was approximately 17.5 in both groups.

During weeks 1-3, the mean change in weekly attack frequency was −8.7 in the galcanezumab group and −5.2 for controls. The difference between groups was statistically significant. The percentage of participants with a reduction in weekly attack frequency of at least 50% at week 3 was 76% for galcanezumab versus 57% for placebo. The between-group differences in these endpoints were statistically significant.

The discontinuation rate was 8% (4 participants) in the galcanezumab group and 21% (12 participants) in the placebo group. Eight participants (14%) in the placebo group discontinued treatment because of lack of efficacy, compared with one participant (2%) in the galcanezumab group. The researchers observed no clinically meaningful differences between treatment groups on tolerability or safety parameters except for a greater incidence of injection-site pain with galcanezumab versus placebo (8.2% vs. 0%).

Eli Lilly and Co. sponsored the study. Dr. Dodick has a consulting relationship with the company.

[email protected]

SOURCE: Bardos JN et al. AAN 2019, Abstract 02.004.

PHILADELPHIA – Galcanezumab reduces weekly attack frequency in patients with episodic cluster headache, according to study results presented at the annual meeting of the American Academy of Neurology. The treatment has a similar safety profile in this patient population as it has among people with episodic or chronic migraine, said the researchers.

Calcitonin gene-related peptide (CGRP) has an important role in the pathogenesis of cluster headache. Galcanezumab (Emgality)is a humanized monoclonal antibody that binds to CGRP. Eli Lilly & Co. developed the molecule as a treatment for migraine. Cluster headache is characterized by recurrent unilateral headache attacks accompanied by autonomic symptoms. The most common acute treatments for cluster headache are sumatriptan (Imitrex) and high-flow oxygen, but some patients do not respond to these therapies.

David W. Dodick, MD, director of the headache, sports neurology, and concussion programs at Mayo Clinic in Phoenix, and colleagues conducted a trial to evaluate the efficacy and safety of galcanezumab in patients with episodic cluster headache.

After screening, participants underwent a prospective baseline diary phase for 7 consecutive days. The investigators subsequently randomized patients in equal groups to galcanezumab (300 mg subcutaneously) or placebo. Treatment was administered subcutaneously once monthly. The double-blind treatment period lasted for 8 weeks, and a washout period followed. The trial’s primary endpoint was the overall mean change from baseline in weekly cluster headache attack frequency during weeks 1-3, as recorded in patient diaries. The main secondary endpoint was the proportion of patients who had a reduction in weekly cluster headache attack frequency of 50% or more at week 3.

In all, 49 patients were randomized to galcanezumab, and 57 were randomized to placebo. Mean age was 45-47 years. Between 82% and 84% of patients were male. The mean number of weekly cluster headache attacks at baseline was approximately 17.5 in both groups.

During weeks 1-3, the mean change in weekly attack frequency was −8.7 in the galcanezumab group and −5.2 for controls. The difference between groups was statistically significant. The percentage of participants with a reduction in weekly attack frequency of at least 50% at week 3 was 76% for galcanezumab versus 57% for placebo. The between-group differences in these endpoints were statistically significant.

The discontinuation rate was 8% (4 participants) in the galcanezumab group and 21% (12 participants) in the placebo group. Eight participants (14%) in the placebo group discontinued treatment because of lack of efficacy, compared with one participant (2%) in the galcanezumab group. The researchers observed no clinically meaningful differences between treatment groups on tolerability or safety parameters except for a greater incidence of injection-site pain with galcanezumab versus placebo (8.2% vs. 0%).

Eli Lilly and Co. sponsored the study. Dr. Dodick has a consulting relationship with the company.

[email protected]

SOURCE: Bardos JN et al. AAN 2019, Abstract 02.004.

PHILADELPHIA – Fremanezumab was efficacious in migraine patients who had not benefited from taking other migraine preventive medication, according to a poster presented at the annual meeting of the American Academy of Neurology.

To assess the efficacy of fremanezumab in patients with migraine who had not received relief from trying at least one prior preventive migraine medication, Peter McAllister, MD and colleagues analyzed data from 2 phase 3 trials (HALO EM and HALO CM). Trial participants had either episodic or chronic migraine, confirmed during a 28-day pretreatment baseline period, then received subcutaneous fremanezumab quarterly (675 mg at baseline and placebo at weeks 4 and 8), monthly (for chronic migraine: 675 mg at baseline and 225 mg at weeks 4 and 8; for episodic migraine: 225 mg at baseline and weeks 4 and 8), or placebo (at baseline and weeks 4 and 8).

The present analysis included data from 186 patients with episodic migraine and 407 patients with chronic migraine, which represents the subgroup of study participants in the larger HALO trials who had failed at least one prior preventive migraine medication. Dr. McAllister, who is cofounder and chief medical officer at the New England Institute for Clinical Research in Stamford, Connecticut, and his colleagues, assessed mean changes from baseline in the monthly average number of headache days of at least moderate severity or the monthly average number of migraine days during the 12-week treatment period.

In patients with chronic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly [least-squares mean change]: –4.0, P less than 0.0001; monthly: –4.5, P less than 0.0001) compared with placebo (–1.8). There were similar reductions in the number of migraine days (quarterly: –4.1, P = 0.0027; monthly: –4.8, P less than 0.0001) compared with placebo (–2.3).

In patients with episodic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly: –3.1, P less than 0.0001; monthly: –3.2, P less than 0.0001) compared with placebo (–0.8). There were similar reductions in the number of migraine days (quarterly: –3.3, P = 0.0015; monthly: –3.7, P less than 0.0001) compared with placebo (–1.3).

“The phase 3 HALO CM and HALO EM trials showed that fremanezumab is efficacious in patients who failed one or more prior preventive medication, a potentially difficult-to-treat population,” Dr. McAllister and colleagues said in their poster.

“Effect sizes in this subgroup were greater than those in the overall trial population,” they said. In addition, “both quarterly and monthly fremanezumab were well-tolerated in this subgroup.”

This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel.

[email protected]

SOURCE: McAllister P et al. AAN 2019. P1.10-011.

PHILADELPHIA – Fremanezumab was efficacious in migraine patients who had not benefited from taking other migraine preventive medication, according to a poster presented at the annual meeting of the American Academy of Neurology.

To assess the efficacy of fremanezumab in patients with migraine who had not received relief from trying at least one prior preventive migraine medication, Peter McAllister, MD and colleagues analyzed data from 2 phase 3 trials (HALO EM and HALO CM). Trial participants had either episodic or chronic migraine, confirmed during a 28-day pretreatment baseline period, then received subcutaneous fremanezumab quarterly (675 mg at baseline and placebo at weeks 4 and 8), monthly (for chronic migraine: 675 mg at baseline and 225 mg at weeks 4 and 8; for episodic migraine: 225 mg at baseline and weeks 4 and 8), or placebo (at baseline and weeks 4 and 8).

The present analysis included data from 186 patients with episodic migraine and 407 patients with chronic migraine, which represents the subgroup of study participants in the larger HALO trials who had failed at least one prior preventive migraine medication. Dr. McAllister, who is cofounder and chief medical officer at the New England Institute for Clinical Research in Stamford, Connecticut, and his colleagues, assessed mean changes from baseline in the monthly average number of headache days of at least moderate severity or the monthly average number of migraine days during the 12-week treatment period.

In patients with chronic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly [least-squares mean change]: –4.0, P less than 0.0001; monthly: –4.5, P less than 0.0001) compared with placebo (–1.8). There were similar reductions in the number of migraine days (quarterly: –4.1, P = 0.0027; monthly: –4.8, P less than 0.0001) compared with placebo (–2.3).

In patients with episodic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly: –3.1, P less than 0.0001; monthly: –3.2, P less than 0.0001) compared with placebo (–0.8). There were similar reductions in the number of migraine days (quarterly: –3.3, P = 0.0015; monthly: –3.7, P less than 0.0001) compared with placebo (–1.3).

“The phase 3 HALO CM and HALO EM trials showed that fremanezumab is efficacious in patients who failed one or more prior preventive medication, a potentially difficult-to-treat population,” Dr. McAllister and colleagues said in their poster.

“Effect sizes in this subgroup were greater than those in the overall trial population,” they said. In addition, “both quarterly and monthly fremanezumab were well-tolerated in this subgroup.”

This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel.

[email protected]

SOURCE: McAllister P et al. AAN 2019. P1.10-011.

PHILADELPHIA – Fremanezumab was efficacious in migraine patients who had not benefited from taking other migraine preventive medication, according to a poster presented at the annual meeting of the American Academy of Neurology.

To assess the efficacy of fremanezumab in patients with migraine who had not received relief from trying at least one prior preventive migraine medication, Peter McAllister, MD and colleagues analyzed data from 2 phase 3 trials (HALO EM and HALO CM). Trial participants had either episodic or chronic migraine, confirmed during a 28-day pretreatment baseline period, then received subcutaneous fremanezumab quarterly (675 mg at baseline and placebo at weeks 4 and 8), monthly (for chronic migraine: 675 mg at baseline and 225 mg at weeks 4 and 8; for episodic migraine: 225 mg at baseline and weeks 4 and 8), or placebo (at baseline and weeks 4 and 8).

The present analysis included data from 186 patients with episodic migraine and 407 patients with chronic migraine, which represents the subgroup of study participants in the larger HALO trials who had failed at least one prior preventive migraine medication. Dr. McAllister, who is cofounder and chief medical officer at the New England Institute for Clinical Research in Stamford, Connecticut, and his colleagues, assessed mean changes from baseline in the monthly average number of headache days of at least moderate severity or the monthly average number of migraine days during the 12-week treatment period.

In patients with chronic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly [least-squares mean change]: –4.0, P less than 0.0001; monthly: –4.5, P less than 0.0001) compared with placebo (–1.8). There were similar reductions in the number of migraine days (quarterly: –4.1, P = 0.0027; monthly: –4.8, P less than 0.0001) compared with placebo (–2.3).

In patients with episodic migraine, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly: –3.1, P less than 0.0001; monthly: –3.2, P less than 0.0001) compared with placebo (–0.8). There were similar reductions in the number of migraine days (quarterly: –3.3, P = 0.0015; monthly: –3.7, P less than 0.0001) compared with placebo (–1.3).

“The phase 3 HALO CM and HALO EM trials showed that fremanezumab is efficacious in patients who failed one or more prior preventive medication, a potentially difficult-to-treat population,” Dr. McAllister and colleagues said in their poster.

“Effect sizes in this subgroup were greater than those in the overall trial population,” they said. In addition, “both quarterly and monthly fremanezumab were well-tolerated in this subgroup.”

This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel.

[email protected]

SOURCE: McAllister P et al. AAN 2019. P1.10-011.