Migraine ICYMI

Anatomic localization (the hypothalamus as a key and early mediator in the pathophysiology of migraine), common mediating signaling molecules (such as serotonin and dopamine), and the discovery of a new central nervous system waste removal system, the glymphatic system, all point to a common pathophysiology manifesting in migraine and sleep problems, according to recent research. Patients consistently report poor sleep prior to migraine attacks and during them, identifying poor sleep as a migraine trigger. However, anecdotally, sleep is reported to serve a therapeutic role in terminating headache. Researchers reviewed studies of sleep and migraine from the last 2 decades, utilizing validated subjective and objective measures of sleep and to explore potential mechanisms underlying this complex relationship by incorporating recent advances in neuroscience. They specifically focused on:

• insomnia,
• obstructive sleep apnea,
• parasomnias,
• sleep-related movement disorders, and
• rapid eye movement (REM) sleep-related disorders and their relationship to migraine.

In addition, parts of brainstem‐cortical networks involved in sleep physiology are unintentionally being identified as important factors in the common migraine pathway.

Vgontzas A, Pavlović JM. Sleep disorders and migraine: Review of literature and potential pathophysiology mechanisms. [Published online ahead of print August 8, 2018]. Headache. doi:10.1111/head.13358.

Anatomic localization (the hypothalamus as a key and early mediator in the pathophysiology of migraine), common mediating signaling molecules (such as serotonin and dopamine), and the discovery of a new central nervous system waste removal system, the glymphatic system, all point to a common pathophysiology manifesting in migraine and sleep problems, according to recent research. Patients consistently report poor sleep prior to migraine attacks and during them, identifying poor sleep as a migraine trigger. However, anecdotally, sleep is reported to serve a therapeutic role in terminating headache. Researchers reviewed studies of sleep and migraine from the last 2 decades, utilizing validated subjective and objective measures of sleep and to explore potential mechanisms underlying this complex relationship by incorporating recent advances in neuroscience. They specifically focused on:

• insomnia,
• obstructive sleep apnea,
• parasomnias,
• sleep-related movement disorders, and
• rapid eye movement (REM) sleep-related disorders and their relationship to migraine.

In addition, parts of brainstem‐cortical networks involved in sleep physiology are unintentionally being identified as important factors in the common migraine pathway.

Vgontzas A, Pavlović JM. Sleep disorders and migraine: Review of literature and potential pathophysiology mechanisms. [Published online ahead of print August 8, 2018]. Headache. doi:10.1111/head.13358.

Anatomic localization (the hypothalamus as a key and early mediator in the pathophysiology of migraine), common mediating signaling molecules (such as serotonin and dopamine), and the discovery of a new central nervous system waste removal system, the glymphatic system, all point to a common pathophysiology manifesting in migraine and sleep problems, according to recent research. Patients consistently report poor sleep prior to migraine attacks and during them, identifying poor sleep as a migraine trigger. However, anecdotally, sleep is reported to serve a therapeutic role in terminating headache. Researchers reviewed studies of sleep and migraine from the last 2 decades, utilizing validated subjective and objective measures of sleep and to explore potential mechanisms underlying this complex relationship by incorporating recent advances in neuroscience. They specifically focused on:

• insomnia,
• obstructive sleep apnea,
• parasomnias,
• sleep-related movement disorders, and
• rapid eye movement (REM) sleep-related disorders and their relationship to migraine.

In addition, parts of brainstem‐cortical networks involved in sleep physiology are unintentionally being identified as important factors in the common migraine pathway.

Vgontzas A, Pavlović JM. Sleep disorders and migraine: Review of literature and potential pathophysiology mechanisms. [Published online ahead of print August 8, 2018]. Headache. doi:10.1111/head.13358.

The presence of a sleep disorder is associated with more frequent and severe migraine and portends a poorer headache prognosis, according to recent research that focuses on clinical assessment and treatment of sleep disorders. Interestingly, the disorders linked to migraine are quite varied, including insomnia, snoring and obstructive sleep apnea, restless legs, circadian rhythm disorders, and narcolepsy. Insomnia is by far the most common sleep disorder in headache patients.  New developments in treatment have produced abbreviated and cost‐effective therapies for insomnia and obstructive sleep apnea that may reach a larger population. Recommendations include:

• behavioral sleep regulation, shown in recent controlled trials to decrease migraine frequency,
• management for sleep apnea headache, and
• cognitive behavioral therapy (CBT) for insomnia abbreviated for the physician practice setting.

There is no empirical evidence that sleep evaluation should delay or supersede usual headache care. Rather, sleep management is complimentary to standard headache practice.

Rains JC. Sleep and migraine: Assessment and treatment of comorbid sleep disorders. [Published online ahead of print August 10, 2018]. Headache. doi:10.1111/head.13357.

The presence of a sleep disorder is associated with more frequent and severe migraine and portends a poorer headache prognosis, according to recent research that focuses on clinical assessment and treatment of sleep disorders. Interestingly, the disorders linked to migraine are quite varied, including insomnia, snoring and obstructive sleep apnea, restless legs, circadian rhythm disorders, and narcolepsy. Insomnia is by far the most common sleep disorder in headache patients.  New developments in treatment have produced abbreviated and cost‐effective therapies for insomnia and obstructive sleep apnea that may reach a larger population. Recommendations include:

• behavioral sleep regulation, shown in recent controlled trials to decrease migraine frequency,
• management for sleep apnea headache, and
• cognitive behavioral therapy (CBT) for insomnia abbreviated for the physician practice setting.

There is no empirical evidence that sleep evaluation should delay or supersede usual headache care. Rather, sleep management is complimentary to standard headache practice.

Rains JC. Sleep and migraine: Assessment and treatment of comorbid sleep disorders. [Published online ahead of print August 10, 2018]. Headache. doi:10.1111/head.13357.

The presence of a sleep disorder is associated with more frequent and severe migraine and portends a poorer headache prognosis, according to recent research that focuses on clinical assessment and treatment of sleep disorders. Interestingly, the disorders linked to migraine are quite varied, including insomnia, snoring and obstructive sleep apnea, restless legs, circadian rhythm disorders, and narcolepsy. Insomnia is by far the most common sleep disorder in headache patients.  New developments in treatment have produced abbreviated and cost‐effective therapies for insomnia and obstructive sleep apnea that may reach a larger population. Recommendations include:

• behavioral sleep regulation, shown in recent controlled trials to decrease migraine frequency,
• management for sleep apnea headache, and
• cognitive behavioral therapy (CBT) for insomnia abbreviated for the physician practice setting.

There is no empirical evidence that sleep evaluation should delay or supersede usual headache care. Rather, sleep management is complimentary to standard headache practice.

Rains JC. Sleep and migraine: Assessment and treatment of comorbid sleep disorders. [Published online ahead of print August 10, 2018]. Headache. doi:10.1111/head.13357.

Patients with comorbid fibromyalgia and migraine report more depressive symptoms, higher headache intensity, and are more likely to have severe headache-related disability as compared to controls without fibromyalgia, according to a recent study. Cases of comorbid fibromyalgia and migraine were identified using a prospectively maintained headache database at Mayo Clinic Rochester. Depressive symptoms as assessed by Patient Health Questionnaire (PHQ)-9, intensity of headache, and migraine-related disability as assessed by Migraine Disability Assessment (MIDAS) were primary measures used to compare migraine patients with comorbid fibromyalgia vs those without. One hundred and fifty-seven cases and 471 controls were identified. Researchers found:

• Patients with comorbid fibromyalgia reported significantly higher PHQ-9 scores (OR 1.08) and headache intensity scores (odds ratio [OR] 1.149).
• There was no significant difference in migraine-related disability (OR 1.002).
• Patients with fibromyalgia were more likely to score in a higher category of depression severity (OR 1.467) and more likely to score in a higher category of migraine-related disability (OR 1.23).

Whealy M, Nanda S, Vincent A, Mandrekar J, Cutrer FM. Fibromyalgia in migraine: A retrospective cohort study. J Headache Pain. 2018;19(1):61. doi:10.1186/s10194-018-0892-9.

Patients with comorbid fibromyalgia and migraine report more depressive symptoms, higher headache intensity, and are more likely to have severe headache-related disability as compared to controls without fibromyalgia, according to a recent study. Cases of comorbid fibromyalgia and migraine were identified using a prospectively maintained headache database at Mayo Clinic Rochester. Depressive symptoms as assessed by Patient Health Questionnaire (PHQ)-9, intensity of headache, and migraine-related disability as assessed by Migraine Disability Assessment (MIDAS) were primary measures used to compare migraine patients with comorbid fibromyalgia vs those without. One hundred and fifty-seven cases and 471 controls were identified. Researchers found:

• Patients with comorbid fibromyalgia reported significantly higher PHQ-9 scores (OR 1.08) and headache intensity scores (odds ratio [OR] 1.149).
• There was no significant difference in migraine-related disability (OR 1.002).
• Patients with fibromyalgia were more likely to score in a higher category of depression severity (OR 1.467) and more likely to score in a higher category of migraine-related disability (OR 1.23).

Whealy M, Nanda S, Vincent A, Mandrekar J, Cutrer FM. Fibromyalgia in migraine: A retrospective cohort study. J Headache Pain. 2018;19(1):61. doi:10.1186/s10194-018-0892-9.

Patients with comorbid fibromyalgia and migraine report more depressive symptoms, higher headache intensity, and are more likely to have severe headache-related disability as compared to controls without fibromyalgia, according to a recent study. Cases of comorbid fibromyalgia and migraine were identified using a prospectively maintained headache database at Mayo Clinic Rochester. Depressive symptoms as assessed by Patient Health Questionnaire (PHQ)-9, intensity of headache, and migraine-related disability as assessed by Migraine Disability Assessment (MIDAS) were primary measures used to compare migraine patients with comorbid fibromyalgia vs those without. One hundred and fifty-seven cases and 471 controls were identified. Researchers found:

• Patients with comorbid fibromyalgia reported significantly higher PHQ-9 scores (OR 1.08) and headache intensity scores (odds ratio [OR] 1.149).
• There was no significant difference in migraine-related disability (OR 1.002).
• Patients with fibromyalgia were more likely to score in a higher category of depression severity (OR 1.467) and more likely to score in a higher category of migraine-related disability (OR 1.23).

Whealy M, Nanda S, Vincent A, Mandrekar J, Cutrer FM. Fibromyalgia in migraine: A retrospective cohort study. J Headache Pain. 2018;19(1):61. doi:10.1186/s10194-018-0892-9.

SAN FRANCISCO—Among patients with episodic cluster headache, galcanezumab significantly reduced weekly attack frequency, according to the results of a phase III trial presented at the 60th Annual Scientific Meeting of the American Headache Society. Results of an eight-week, double-blind, placebo-controlled clinical trial showed that galcanezumab (300 mg SC) significantly reduced the weekly cluster headache attack frequency across weeks one to three, which was the study’s primary end point, and resulted in a significantly greater percentage of patients achieving a 50% or greater reduction in their weekly cluster headache attack frequency at week three.

James M. Martinez, MD, a medical fellow at Eli Lilly, Indianapolis, Indiana, and study collaborators sought to determine if galcanezumab (aka LY2951742), a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP), is efficacious as a preventive treatment of episodic cluster headache.

A phase III study was designed to assess the efficacy and safety of galcanezumab in individuals with episodic cluster headache, as defined by ICHD-3 beta criteria. This study comprised a screening period; a prospective baseline period; an eight-week, double-blind, placebo-controlled treatment period; and a four-month posttreatment washout period.

In the double-blind treatment period, participants were randomized 1:1 to galcanezumab 300 mg SC (n = 49) or placebo (n = 57) once monthly for two months. The primary end point was the overall mean change from baseline in weekly cluster headache attack frequency across weeks one to three. The key secondary end point was the proportion of participants achieving a response, defined as a reduction from baseline of 50% or greater in the weekly cluster headache attack frequency at week three. Other secondary end points included proportion of participants very much or much better based on Patient Global Impression of Improvement (PGI-I) at weeks four and eight.

Baseline demographics of the galcanezumab and placebo groups were similar. Mean age was 47 and 45, respectively; 84% and 82%, respectively, were male. The mean number of weekly cluster headache attacks in the baseline period was 17.8 for the galcanezumab group and 17.3 for the placebo group. Overall, four participants (8%) in the galcanezumab treatment group discontinued therapy during the double-blind period versus 12 (21%) in the placebo group. In the placebo group, eight participants (14%) discontinued treatment due to lack of efficacy versus one (2%) in the galcanezumab group. The mean change in weekly cluster headache attack frequency across weeks one to three was –8.7 for galcanezumab versus –5.2 for placebo (difference between treatment groups in mean change, –3.5). The proportion of participants achieving a 50% or greater reduction in weekly cluster headache attack frequency was 76% for galcanezumab versus 57% for placebo. The proportion of participants very much or much better based on PGI-I was significantly greater with galcanezumab versus placebo at week four (73% vs 46%) but not at week eight (72% vs 66%). There were no clinically meaningful differences between treatment groups on tolerability or safety parameters except for a statistically significantly greater incidence of injection site pain with galcanezumab versus placebo (8.2% vs 0%), which was similar to the safety profile seen previously in patients with episodic and chronic migraine.

—Glenn S. Williams

SAN FRANCISCO—Among patients with episodic cluster headache, galcanezumab significantly reduced weekly attack frequency, according to the results of a phase III trial presented at the 60th Annual Scientific Meeting of the American Headache Society. Results of an eight-week, double-blind, placebo-controlled clinical trial showed that galcanezumab (300 mg SC) significantly reduced the weekly cluster headache attack frequency across weeks one to three, which was the study’s primary end point, and resulted in a significantly greater percentage of patients achieving a 50% or greater reduction in their weekly cluster headache attack frequency at week three.

James M. Martinez, MD, a medical fellow at Eli Lilly, Indianapolis, Indiana, and study collaborators sought to determine if galcanezumab (aka LY2951742), a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP), is efficacious as a preventive treatment of episodic cluster headache.

A phase III study was designed to assess the efficacy and safety of galcanezumab in individuals with episodic cluster headache, as defined by ICHD-3 beta criteria. This study comprised a screening period; a prospective baseline period; an eight-week, double-blind, placebo-controlled treatment period; and a four-month posttreatment washout period.

In the double-blind treatment period, participants were randomized 1:1 to galcanezumab 300 mg SC (n = 49) or placebo (n = 57) once monthly for two months. The primary end point was the overall mean change from baseline in weekly cluster headache attack frequency across weeks one to three. The key secondary end point was the proportion of participants achieving a response, defined as a reduction from baseline of 50% or greater in the weekly cluster headache attack frequency at week three. Other secondary end points included proportion of participants very much or much better based on Patient Global Impression of Improvement (PGI-I) at weeks four and eight.

Baseline demographics of the galcanezumab and placebo groups were similar. Mean age was 47 and 45, respectively; 84% and 82%, respectively, were male. The mean number of weekly cluster headache attacks in the baseline period was 17.8 for the galcanezumab group and 17.3 for the placebo group. Overall, four participants (8%) in the galcanezumab treatment group discontinued therapy during the double-blind period versus 12 (21%) in the placebo group. In the placebo group, eight participants (14%) discontinued treatment due to lack of efficacy versus one (2%) in the galcanezumab group. The mean change in weekly cluster headache attack frequency across weeks one to three was –8.7 for galcanezumab versus –5.2 for placebo (difference between treatment groups in mean change, –3.5). The proportion of participants achieving a 50% or greater reduction in weekly cluster headache attack frequency was 76% for galcanezumab versus 57% for placebo. The proportion of participants very much or much better based on PGI-I was significantly greater with galcanezumab versus placebo at week four (73% vs 46%) but not at week eight (72% vs 66%). There were no clinically meaningful differences between treatment groups on tolerability or safety parameters except for a statistically significantly greater incidence of injection site pain with galcanezumab versus placebo (8.2% vs 0%), which was similar to the safety profile seen previously in patients with episodic and chronic migraine.

—Glenn S. Williams

SAN FRANCISCO—Among patients with episodic cluster headache, galcanezumab significantly reduced weekly attack frequency, according to the results of a phase III trial presented at the 60th Annual Scientific Meeting of the American Headache Society. Results of an eight-week, double-blind, placebo-controlled clinical trial showed that galcanezumab (300 mg SC) significantly reduced the weekly cluster headache attack frequency across weeks one to three, which was the study’s primary end point, and resulted in a significantly greater percentage of patients achieving a 50% or greater reduction in their weekly cluster headache attack frequency at week three.

James M. Martinez, MD, a medical fellow at Eli Lilly, Indianapolis, Indiana, and study collaborators sought to determine if galcanezumab (aka LY2951742), a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP), is efficacious as a preventive treatment of episodic cluster headache.

A phase III study was designed to assess the efficacy and safety of galcanezumab in individuals with episodic cluster headache, as defined by ICHD-3 beta criteria. This study comprised a screening period; a prospective baseline period; an eight-week, double-blind, placebo-controlled treatment period; and a four-month posttreatment washout period.

In the double-blind treatment period, participants were randomized 1:1 to galcanezumab 300 mg SC (n = 49) or placebo (n = 57) once monthly for two months. The primary end point was the overall mean change from baseline in weekly cluster headache attack frequency across weeks one to three. The key secondary end point was the proportion of participants achieving a response, defined as a reduction from baseline of 50% or greater in the weekly cluster headache attack frequency at week three. Other secondary end points included proportion of participants very much or much better based on Patient Global Impression of Improvement (PGI-I) at weeks four and eight.

Baseline demographics of the galcanezumab and placebo groups were similar. Mean age was 47 and 45, respectively; 84% and 82%, respectively, were male. The mean number of weekly cluster headache attacks in the baseline period was 17.8 for the galcanezumab group and 17.3 for the placebo group. Overall, four participants (8%) in the galcanezumab treatment group discontinued therapy during the double-blind period versus 12 (21%) in the placebo group. In the placebo group, eight participants (14%) discontinued treatment due to lack of efficacy versus one (2%) in the galcanezumab group. The mean change in weekly cluster headache attack frequency across weeks one to three was –8.7 for galcanezumab versus –5.2 for placebo (difference between treatment groups in mean change, –3.5). The proportion of participants achieving a 50% or greater reduction in weekly cluster headache attack frequency was 76% for galcanezumab versus 57% for placebo. The proportion of participants very much or much better based on PGI-I was significantly greater with galcanezumab versus placebo at week four (73% vs 46%) but not at week eight (72% vs 66%). There were no clinically meaningful differences between treatment groups on tolerability or safety parameters except for a statistically significantly greater incidence of injection site pain with galcanezumab versus placebo (8.2% vs 0%), which was similar to the safety profile seen previously in patients with episodic and chronic migraine.

—Glenn S. Williams

SAN FRANCISCO—Patients with chronic migraine are significantly more likely than those with episodic migraine to report that headaches contribute to relationship problems and have a detrimental effect on family life, researchers said at the 60th Annual Scientific Meeting of the American Headache Society. Negative effects on family life include a delay in having children and having fewer children.

Migraine can detract from many aspects of family life and affect all members of the patient’s family. Dawn C. Buse, PhD, Clinical Professor of Neurology at Albert Einstein College of Medicine in the Bronx, New York, and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study to understand the effects of episodic and chronic migraine on a person’s relationships and family life.

An Analysis of CaMEO Data

The CaMEO study is a prospective, longitudinal, web-based survey designed to characterize the impact of migraine, among other objectives, in a systematic US sample of people meeting modified ICHD-2R criteria. A total of 19,891 respondents met study criteria, including criteria for migraine, and were invited to complete the Family Burden Module (FBM), which assessed the impact, perception, and emotions related to living with migraine among people with migraine and their family members.

Dr. Buse and colleagues presented the results of migraineurs’ responses to the FBM regarding relationships with spouses or significant others and relationships with children living at home. The investigators stratified migraineurs by episodic migraine (ie, those with fewer than 14 headache days per month) and chronic migraine (ie, those with 15 or more headache days per month). Migraineurs were asked about their current relationship status (ie, in a current relationship or not, living together or not). Questions evaluated how headaches had affected past or current relationships with Likert-type response options that corresponded to degrees of disagreement or agreement. Dr. Buse’s group analyzed items by relationship status, episodic or chronic migraine status, and gender.

Women and Men Were Affected Similarly

In all, 13,064 respondents provided valid data. Of this population, 11,938 (91.4%) had episodic migraine and 1,126 (8.6%) had chronic migraine. Of those not currently in a relationship (n = 3,189), respondents with chronic migraine were significantly more likely to indicate that headaches had contributed to relationship problems (37.0%), compared with patients with episodic migraine (15.0%). Of those in a relationship but not living together (n = 1,323), 43.9% of respondents with chronic migraine indicated that headaches were causing relationship concerns or were preventing a closer relationship, such as moving in together or getting married, compared with 15.8% of patients with episodic migraine. The responses were similar among men (18.0%) and women (17.8%).

About 47% of respondents with chronic migraine reported that headaches have caused one or more previous relationship to end or have other problems, compared with 18.2% of respondents with episodic migraine. Headache contributions to relationship problems (ie, breakup or other difficulties) were similar among men (20.6%) and women (19.9%).

Of those in a relationship and living together (n = 8,127), 78.2% of respondents with chronic migraine agreed that they would be a better partner if they did not have headaches, compared with 46.2% of respondents with episodic migraine. Furthermore, 9.6% of patients with chronic migraine had delayed having children or had fewer children, compared with 2.6% of patients with episodic migraine. The researchers observed no differences between men and women.

SAN FRANCISCO—Patients with chronic migraine are significantly more likely than those with episodic migraine to report that headaches contribute to relationship problems and have a detrimental effect on family life, researchers said at the 60th Annual Scientific Meeting of the American Headache Society. Negative effects on family life include a delay in having children and having fewer children.

Migraine can detract from many aspects of family life and affect all members of the patient’s family. Dawn C. Buse, PhD, Clinical Professor of Neurology at Albert Einstein College of Medicine in the Bronx, New York, and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study to understand the effects of episodic and chronic migraine on a person’s relationships and family life.

An Analysis of CaMEO Data

The CaMEO study is a prospective, longitudinal, web-based survey designed to characterize the impact of migraine, among other objectives, in a systematic US sample of people meeting modified ICHD-2R criteria. A total of 19,891 respondents met study criteria, including criteria for migraine, and were invited to complete the Family Burden Module (FBM), which assessed the impact, perception, and emotions related to living with migraine among people with migraine and their family members.

Dr. Buse and colleagues presented the results of migraineurs’ responses to the FBM regarding relationships with spouses or significant others and relationships with children living at home. The investigators stratified migraineurs by episodic migraine (ie, those with fewer than 14 headache days per month) and chronic migraine (ie, those with 15 or more headache days per month). Migraineurs were asked about their current relationship status (ie, in a current relationship or not, living together or not). Questions evaluated how headaches had affected past or current relationships with Likert-type response options that corresponded to degrees of disagreement or agreement. Dr. Buse’s group analyzed items by relationship status, episodic or chronic migraine status, and gender.

Women and Men Were Affected Similarly

In all, 13,064 respondents provided valid data. Of this population, 11,938 (91.4%) had episodic migraine and 1,126 (8.6%) had chronic migraine. Of those not currently in a relationship (n = 3,189), respondents with chronic migraine were significantly more likely to indicate that headaches had contributed to relationship problems (37.0%), compared with patients with episodic migraine (15.0%). Of those in a relationship but not living together (n = 1,323), 43.9% of respondents with chronic migraine indicated that headaches were causing relationship concerns or were preventing a closer relationship, such as moving in together or getting married, compared with 15.8% of patients with episodic migraine. The responses were similar among men (18.0%) and women (17.8%).

About 47% of respondents with chronic migraine reported that headaches have caused one or more previous relationship to end or have other problems, compared with 18.2% of respondents with episodic migraine. Headache contributions to relationship problems (ie, breakup or other difficulties) were similar among men (20.6%) and women (19.9%).

Of those in a relationship and living together (n = 8,127), 78.2% of respondents with chronic migraine agreed that they would be a better partner if they did not have headaches, compared with 46.2% of respondents with episodic migraine. Furthermore, 9.6% of patients with chronic migraine had delayed having children or had fewer children, compared with 2.6% of patients with episodic migraine. The researchers observed no differences between men and women.

SAN FRANCISCO—Patients with chronic migraine are significantly more likely than those with episodic migraine to report that headaches contribute to relationship problems and have a detrimental effect on family life, researchers said at the 60th Annual Scientific Meeting of the American Headache Society. Negative effects on family life include a delay in having children and having fewer children.

Migraine can detract from many aspects of family life and affect all members of the patient’s family. Dawn C. Buse, PhD, Clinical Professor of Neurology at Albert Einstein College of Medicine in the Bronx, New York, and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study to understand the effects of episodic and chronic migraine on a person’s relationships and family life.

An Analysis of CaMEO Data

The CaMEO study is a prospective, longitudinal, web-based survey designed to characterize the impact of migraine, among other objectives, in a systematic US sample of people meeting modified ICHD-2R criteria. A total of 19,891 respondents met study criteria, including criteria for migraine, and were invited to complete the Family Burden Module (FBM), which assessed the impact, perception, and emotions related to living with migraine among people with migraine and their family members.

Dr. Buse and colleagues presented the results of migraineurs’ responses to the FBM regarding relationships with spouses or significant others and relationships with children living at home. The investigators stratified migraineurs by episodic migraine (ie, those with fewer than 14 headache days per month) and chronic migraine (ie, those with 15 or more headache days per month). Migraineurs were asked about their current relationship status (ie, in a current relationship or not, living together or not). Questions evaluated how headaches had affected past or current relationships with Likert-type response options that corresponded to degrees of disagreement or agreement. Dr. Buse’s group analyzed items by relationship status, episodic or chronic migraine status, and gender.

Women and Men Were Affected Similarly

In all, 13,064 respondents provided valid data. Of this population, 11,938 (91.4%) had episodic migraine and 1,126 (8.6%) had chronic migraine. Of those not currently in a relationship (n = 3,189), respondents with chronic migraine were significantly more likely to indicate that headaches had contributed to relationship problems (37.0%), compared with patients with episodic migraine (15.0%). Of those in a relationship but not living together (n = 1,323), 43.9% of respondents with chronic migraine indicated that headaches were causing relationship concerns or were preventing a closer relationship, such as moving in together or getting married, compared with 15.8% of patients with episodic migraine. The responses were similar among men (18.0%) and women (17.8%).

About 47% of respondents with chronic migraine reported that headaches have caused one or more previous relationship to end or have other problems, compared with 18.2% of respondents with episodic migraine. Headache contributions to relationship problems (ie, breakup or other difficulties) were similar among men (20.6%) and women (19.9%).

Of those in a relationship and living together (n = 8,127), 78.2% of respondents with chronic migraine agreed that they would be a better partner if they did not have headaches, compared with 46.2% of respondents with episodic migraine. Furthermore, 9.6% of patients with chronic migraine had delayed having children or had fewer children, compared with 2.6% of patients with episodic migraine. The researchers observed no differences between men and women.

SAN FRANCISCO—Among a cohort of recently deployed soldiers, headaches were frequent but were more severe, frequent, and migrainous if associated with concussion, according to a report presented at the 60th Annual Scientific Meeting of the American Headache Society. At one-year follow-up, headache frequency had decreased in soldiers with posttraumatic headache (PTH) but remained higher in this group than in those whose headaches were presumed to be unrelated to head injury, said Ann I. Scher, PhD, Director and Professor of Preventive Medicine and Biostatistics at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, and colleagues.

“There are limited data on the phenotypic differences between headaches related to mild traumatic brain injury and ‘regular’ headaches,” Dr. Scher said. “A better understanding of the posttraumatic headache phenotype will inform the design of interventional studies for this difficult to treat population.”

SAN FRANCISCO—Among a cohort of recently deployed soldiers, headaches were frequent but were more severe, frequent, and migrainous if associated with concussion, according to a report presented at the 60th Annual Scientific Meeting of the American Headache Society. At one-year follow-up, headache frequency had decreased in soldiers with posttraumatic headache (PTH) but remained higher in this group than in those whose headaches were presumed to be unrelated to head injury, said Ann I. Scher, PhD, Director and Professor of Preventive Medicine and Biostatistics at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, and colleagues.

“There are limited data on the phenotypic differences between headaches related to mild traumatic brain injury and ‘regular’ headaches,” Dr. Scher said. “A better understanding of the posttraumatic headache phenotype will inform the design of interventional studies for this difficult to treat population.”

SAN FRANCISCO—Among a cohort of recently deployed soldiers, headaches were frequent but were more severe, frequent, and migrainous if associated with concussion, according to a report presented at the 60th Annual Scientific Meeting of the American Headache Society. At one-year follow-up, headache frequency had decreased in soldiers with posttraumatic headache (PTH) but remained higher in this group than in those whose headaches were presumed to be unrelated to head injury, said Ann I. Scher, PhD, Director and Professor of Preventive Medicine and Biostatistics at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, and colleagues.

“There are limited data on the phenotypic differences between headaches related to mild traumatic brain injury and ‘regular’ headaches,” Dr. Scher said. “A better understanding of the posttraumatic headache phenotype will inform the design of interventional studies for this difficult to treat population.”

SAN FRANCISCO—Chronic migraine is associated with increased age-related cortical thinning of some brain areas and decreased age-related cortical thinning in other areas, according to research presented at the 60th Annual Scientific Meeting of the American Headache Society. It remains uncertain whether these cortical changes are a cause or an effect of chronic migraine.

Age-related cortical integrity had not been explored in chronic migraine previously. To investigate this topic, Yohannes Woubishet Woldeamanuel, MD, Instructor in Neurology and Neurologic Sciences at Stanford University in California, and colleagues enrolled 30 patients with chronic migraine and 30 age- and sex-matched healthy controls into a study. All participants were right-handed. The mean age in the chronic migraine group was 40.5, and the male-to-female ratio was 1:4. Investigators obtained the duration of chronic migraine and lifetime migraine from participants with chronic migraine.

Suggested Reading

Chong CD, Dodick DW, Schlaggar BL, Schwedt TJ. Atypical age-related cortical thinning in episodic migraine. Cephalalgia. 2014;34(14):1115-1124.

Schwedt TJ, Berisha V, Chong CD. Temporal lobe cortical thickness correlations differentiate the migraine brain from the healthy brain. PLoS One. 2015 Feb 13;10(2):e0116687.

SAN FRANCISCO—Chronic migraine is associated with increased age-related cortical thinning of some brain areas and decreased age-related cortical thinning in other areas, according to research presented at the 60th Annual Scientific Meeting of the American Headache Society. It remains uncertain whether these cortical changes are a cause or an effect of chronic migraine.

Age-related cortical integrity had not been explored in chronic migraine previously. To investigate this topic, Yohannes Woubishet Woldeamanuel, MD, Instructor in Neurology and Neurologic Sciences at Stanford University in California, and colleagues enrolled 30 patients with chronic migraine and 30 age- and sex-matched healthy controls into a study. All participants were right-handed. The mean age in the chronic migraine group was 40.5, and the male-to-female ratio was 1:4. Investigators obtained the duration of chronic migraine and lifetime migraine from participants with chronic migraine.

Suggested Reading

Chong CD, Dodick DW, Schlaggar BL, Schwedt TJ. Atypical age-related cortical thinning in episodic migraine. Cephalalgia. 2014;34(14):1115-1124.

Schwedt TJ, Berisha V, Chong CD. Temporal lobe cortical thickness correlations differentiate the migraine brain from the healthy brain. PLoS One. 2015 Feb 13;10(2):e0116687.

SAN FRANCISCO—Chronic migraine is associated with increased age-related cortical thinning of some brain areas and decreased age-related cortical thinning in other areas, according to research presented at the 60th Annual Scientific Meeting of the American Headache Society. It remains uncertain whether these cortical changes are a cause or an effect of chronic migraine.

Age-related cortical integrity had not been explored in chronic migraine previously. To investigate this topic, Yohannes Woubishet Woldeamanuel, MD, Instructor in Neurology and Neurologic Sciences at Stanford University in California, and colleagues enrolled 30 patients with chronic migraine and 30 age- and sex-matched healthy controls into a study. All participants were right-handed. The mean age in the chronic migraine group was 40.5, and the male-to-female ratio was 1:4. Investigators obtained the duration of chronic migraine and lifetime migraine from participants with chronic migraine.

Suggested Reading

Chong CD, Dodick DW, Schlaggar BL, Schwedt TJ. Atypical age-related cortical thinning in episodic migraine. Cephalalgia. 2014;34(14):1115-1124.

Schwedt TJ, Berisha V, Chong CD. Temporal lobe cortical thickness correlations differentiate the migraine brain from the healthy brain. PLoS One. 2015 Feb 13;10(2):e0116687.

SAN FRANCISCO—Unmet treatment needs among migraineurs receiving oral prescription medications include therapies to reduce nausea and disturbed sleep, according to a study described at the 60th Annual Scientific Meeting of the American Headache Society. The population also has unmet needs for therapies that provide pain freedom and rapid onset of action.

In 2017, investigators conducted the Migraine in America Symptoms and Treatment (MAST) study, which focused on migraine symptoms, current treatment patterns, and the assessment of unmet treatment needs. Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in the Bronx, New York, and colleagues examined MAST data to empirically characterize the patterns of poorly controlled migraine and assess corresponding rates of migraine-related disability.

A Survey of American Migraineurs

The MAST survey data were obtained from a general US population sample of migraineurs age 18 and older. Migraineurs were identified using a validated migraine symptom screen based on modified ICHD-3b criteria. Eligible participants had an average of at least one headache day per month during the previous three months.

Respondents provided information about sociodemographics and medication use and responded to a 13-item battery evaluating headache burden and response to medication. The items on the battery were derived from a review of relevant literature, clinician input, and interviews with migraine patients. Participants provided frequency data for each item on a five-point scale ranging from “1) Never” to “5) All or Nearly All of the Time.” To measure construct validity for the scale, the investigators assessed moderate to severe disability for each respondent using the Migraine Disability Assessment Scale (MIDAS).

To determine the underlying structure of unmet treatment needs, Dr. Lipton and colleagues conducted Exploratory Factor Analysis (EFA) among the subset of respondents currently using oral acute prescription medications. They assessed the internal consistency for the derived factors using Cronbach’s alpha. Mean factor scores (range, 1 to 5) were calculated by summing item responses for each factor and dividing by the number of items loading on that factor. The researchers used Mantel-Haenszel Chi Square Test for Trend to evaluate the relationship between mean factor score and rates of moderate to severe migraine-related disability.

Treatment May Act Too Slowly

Among 15,133 respondents meeting inclusion criteria, 3,930 reported current use of acute oral prescription headache medication (mean age, 45.0, 73.6% women, 81.6% Caucasian). Injection and nasal spray medication users were eliminated from the sample. The most commonly endorsed needs were “severe headache attacks come on very rapidly” (52.8%), “attacks reach peak intensity in less than 30 minutes” (50.4%), “severe headache presents upon awakening” (40.9%), and “the return of pain within 24 hours after initial pain relief” (38.6%). EFA identified the following four unmet needs: nausea interference, disturbed sleep, rapid onset, and lack of pain freedom. Internal consistency exceeded acceptable levels for all factors except disturbed sleep. MIDAS disability increased in a clear linear pattern with increasing mean factor scores.

Suggested Reading

Blumenfeld AM, Aurora SK, Laranjo K, Papapetropoulos S. Unmet clinical needs in chronic migraine: Rationale for study and design of COMPEL, an open-label, multicenter study of the long-term efficacy, safety, and tolerability of onabotulinumtoxinA for headache prophylaxis in adults with chronic migraine. BMC Neurol. 2015;15:100.

Lipton RB, Buse DC, Serrano D, et al. Examination of unmet treatment needs among persons with episodic migraine: results of the American Migraine Prevalence and Prevention (AMPP) Study. Headache. 2013;53(8):1300-1311.

SAN FRANCISCO—Unmet treatment needs among migraineurs receiving oral prescription medications include therapies to reduce nausea and disturbed sleep, according to a study described at the 60th Annual Scientific Meeting of the American Headache Society. The population also has unmet needs for therapies that provide pain freedom and rapid onset of action.

In 2017, investigators conducted the Migraine in America Symptoms and Treatment (MAST) study, which focused on migraine symptoms, current treatment patterns, and the assessment of unmet treatment needs. Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in the Bronx, New York, and colleagues examined MAST data to empirically characterize the patterns of poorly controlled migraine and assess corresponding rates of migraine-related disability.

A Survey of American Migraineurs

The MAST survey data were obtained from a general US population sample of migraineurs age 18 and older. Migraineurs were identified using a validated migraine symptom screen based on modified ICHD-3b criteria. Eligible participants had an average of at least one headache day per month during the previous three months.

Respondents provided information about sociodemographics and medication use and responded to a 13-item battery evaluating headache burden and response to medication. The items on the battery were derived from a review of relevant literature, clinician input, and interviews with migraine patients. Participants provided frequency data for each item on a five-point scale ranging from “1) Never” to “5) All or Nearly All of the Time.” To measure construct validity for the scale, the investigators assessed moderate to severe disability for each respondent using the Migraine Disability Assessment Scale (MIDAS).

To determine the underlying structure of unmet treatment needs, Dr. Lipton and colleagues conducted Exploratory Factor Analysis (EFA) among the subset of respondents currently using oral acute prescription medications. They assessed the internal consistency for the derived factors using Cronbach’s alpha. Mean factor scores (range, 1 to 5) were calculated by summing item responses for each factor and dividing by the number of items loading on that factor. The researchers used Mantel-Haenszel Chi Square Test for Trend to evaluate the relationship between mean factor score and rates of moderate to severe migraine-related disability.

Treatment May Act Too Slowly

Among 15,133 respondents meeting inclusion criteria, 3,930 reported current use of acute oral prescription headache medication (mean age, 45.0, 73.6% women, 81.6% Caucasian). Injection and nasal spray medication users were eliminated from the sample. The most commonly endorsed needs were “severe headache attacks come on very rapidly” (52.8%), “attacks reach peak intensity in less than 30 minutes” (50.4%), “severe headache presents upon awakening” (40.9%), and “the return of pain within 24 hours after initial pain relief” (38.6%). EFA identified the following four unmet needs: nausea interference, disturbed sleep, rapid onset, and lack of pain freedom. Internal consistency exceeded acceptable levels for all factors except disturbed sleep. MIDAS disability increased in a clear linear pattern with increasing mean factor scores.

Suggested Reading

Blumenfeld AM, Aurora SK, Laranjo K, Papapetropoulos S. Unmet clinical needs in chronic migraine: Rationale for study and design of COMPEL, an open-label, multicenter study of the long-term efficacy, safety, and tolerability of onabotulinumtoxinA for headache prophylaxis in adults with chronic migraine. BMC Neurol. 2015;15:100.

Lipton RB, Buse DC, Serrano D, et al. Examination of unmet treatment needs among persons with episodic migraine: results of the American Migraine Prevalence and Prevention (AMPP) Study. Headache. 2013;53(8):1300-1311.

SAN FRANCISCO—Unmet treatment needs among migraineurs receiving oral prescription medications include therapies to reduce nausea and disturbed sleep, according to a study described at the 60th Annual Scientific Meeting of the American Headache Society. The population also has unmet needs for therapies that provide pain freedom and rapid onset of action.

In 2017, investigators conducted the Migraine in America Symptoms and Treatment (MAST) study, which focused on migraine symptoms, current treatment patterns, and the assessment of unmet treatment needs. Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in the Bronx, New York, and colleagues examined MAST data to empirically characterize the patterns of poorly controlled migraine and assess corresponding rates of migraine-related disability.

A Survey of American Migraineurs

The MAST survey data were obtained from a general US population sample of migraineurs age 18 and older. Migraineurs were identified using a validated migraine symptom screen based on modified ICHD-3b criteria. Eligible participants had an average of at least one headache day per month during the previous three months.

Respondents provided information about sociodemographics and medication use and responded to a 13-item battery evaluating headache burden and response to medication. The items on the battery were derived from a review of relevant literature, clinician input, and interviews with migraine patients. Participants provided frequency data for each item on a five-point scale ranging from “1) Never” to “5) All or Nearly All of the Time.” To measure construct validity for the scale, the investigators assessed moderate to severe disability for each respondent using the Migraine Disability Assessment Scale (MIDAS).

To determine the underlying structure of unmet treatment needs, Dr. Lipton and colleagues conducted Exploratory Factor Analysis (EFA) among the subset of respondents currently using oral acute prescription medications. They assessed the internal consistency for the derived factors using Cronbach’s alpha. Mean factor scores (range, 1 to 5) were calculated by summing item responses for each factor and dividing by the number of items loading on that factor. The researchers used Mantel-Haenszel Chi Square Test for Trend to evaluate the relationship between mean factor score and rates of moderate to severe migraine-related disability.

Treatment May Act Too Slowly

Among 15,133 respondents meeting inclusion criteria, 3,930 reported current use of acute oral prescription headache medication (mean age, 45.0, 73.6% women, 81.6% Caucasian). Injection and nasal spray medication users were eliminated from the sample. The most commonly endorsed needs were “severe headache attacks come on very rapidly” (52.8%), “attacks reach peak intensity in less than 30 minutes” (50.4%), “severe headache presents upon awakening” (40.9%), and “the return of pain within 24 hours after initial pain relief” (38.6%). EFA identified the following four unmet needs: nausea interference, disturbed sleep, rapid onset, and lack of pain freedom. Internal consistency exceeded acceptable levels for all factors except disturbed sleep. MIDAS disability increased in a clear linear pattern with increasing mean factor scores.

Suggested Reading

Blumenfeld AM, Aurora SK, Laranjo K, Papapetropoulos S. Unmet clinical needs in chronic migraine: Rationale for study and design of COMPEL, an open-label, multicenter study of the long-term efficacy, safety, and tolerability of onabotulinumtoxinA for headache prophylaxis in adults with chronic migraine. BMC Neurol. 2015;15:100.

Lipton RB, Buse DC, Serrano D, et al. Examination of unmet treatment needs among persons with episodic migraine: results of the American Migraine Prevalence and Prevention (AMPP) Study. Headache. 2013;53(8):1300-1311.

SAN FRANCISCO—Lasmiditan may provide pain freedom in the acute treatment of migraine, according to data described at the 60th Annual Scientific Meeting of the American Headache Society. The treatment also may alleviate a patient’s most bothersome symptom (MBS).

Lasmiditan is a novel, centrally acting serotonin (5-HT_1F) agonist that has no vasoconstrictive effect. Linda A. Wietecha, BSN, MS, Medical Advisor for Migraine and Headache Disorders at Eli Lilly and Company in Indianapolis, and colleagues conducted two pivotal phase III studies of lasmiditan to evaluate its efficacy and safety as an acute treatment of migraine.

The two trials, SAMURAI and SPARTAN, were randomized, double-blinded, and placebo-controlled. Eligible participants had a Migraine Disability Assessment Score of 11 or higher (indicating moderate disability) and three to eight migraine attacks per month. The researchers randomized patients to a first dose of treatment, which was taken within four hours of onset of a migraine with moderate or worse severity that was not improving. In the SAMURAI trial, patients were randomized in equal groups to 200 mg of lasmiditan, 100 mg of lasmiditan, or placebo. In the SPARTAN study, patients were randomized in equal groups to 200 mg of lasmiditan, 100 mg of lasmiditan, 50 mg of lasmiditan, or placebo.

For rescue or recurrence treatment, patients took a randomly assigned second dose of the previously assigned lasmiditan dose or placebo. The primary and key secondary analyses compared the proportions of patients in the lasmiditan 200-mg group with that in the placebo group who were free of headache pain and free of their MBS at two hours after the first dose. Treatment-emergent adverse events (TEAEs) were used to assess safety. The investigators performed logistic regression to make comparisons.

At two hours after the first dose, significantly greater proportions of patients taking 200 mg of lasmiditan were free of headache pain and free of MBS, compared with controls. In SAMURAI, the rate of headache pain freedom was 32.2% in the 200-mg group and 15.3% among controls. In SPARTAN, the rate of headache pain freedom was 38.8% in the 200-mg group and 21.3% in controls. The rate of patients free of MBS in SAMURAI was 40.7% in the 200-mg group and 29.5% in controls. The rate of patients free of MBS in SPARTAN was 48.7% in the 200-mg group and 33.5% in controls. For both end points, the investigators also found significant differences for other lasmiditan dose groups, compared with placebo.

The most frequently reported TEAEs with lasmiditan (ie, those occurring with a frequency of 2% or greater and at a rate greater than that among controls) after the first dose were dizziness, paresthesia, somnolence, fatigue, nausea, and lethargy. Most events were mild to moderate in severity.

Suggested Reading

Färkkilä M, Diener HC, Géraud G, et al. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012;11(5):405-413.

SAN FRANCISCO—Lasmiditan may provide pain freedom in the acute treatment of migraine, according to data described at the 60th Annual Scientific Meeting of the American Headache Society. The treatment also may alleviate a patient’s most bothersome symptom (MBS).

Lasmiditan is a novel, centrally acting serotonin (5-HT_1F) agonist that has no vasoconstrictive effect. Linda A. Wietecha, BSN, MS, Medical Advisor for Migraine and Headache Disorders at Eli Lilly and Company in Indianapolis, and colleagues conducted two pivotal phase III studies of lasmiditan to evaluate its efficacy and safety as an acute treatment of migraine.

The two trials, SAMURAI and SPARTAN, were randomized, double-blinded, and placebo-controlled. Eligible participants had a Migraine Disability Assessment Score of 11 or higher (indicating moderate disability) and three to eight migraine attacks per month. The researchers randomized patients to a first dose of treatment, which was taken within four hours of onset of a migraine with moderate or worse severity that was not improving. In the SAMURAI trial, patients were randomized in equal groups to 200 mg of lasmiditan, 100 mg of lasmiditan, or placebo. In the SPARTAN study, patients were randomized in equal groups to 200 mg of lasmiditan, 100 mg of lasmiditan, 50 mg of lasmiditan, or placebo.

For rescue or recurrence treatment, patients took a randomly assigned second dose of the previously assigned lasmiditan dose or placebo. The primary and key secondary analyses compared the proportions of patients in the lasmiditan 200-mg group with that in the placebo group who were free of headache pain and free of their MBS at two hours after the first dose. Treatment-emergent adverse events (TEAEs) were used to assess safety. The investigators performed logistic regression to make comparisons.

At two hours after the first dose, significantly greater proportions of patients taking 200 mg of lasmiditan were free of headache pain and free of MBS, compared with controls. In SAMURAI, the rate of headache pain freedom was 32.2% in the 200-mg group and 15.3% among controls. In SPARTAN, the rate of headache pain freedom was 38.8% in the 200-mg group and 21.3% in controls. The rate of patients free of MBS in SAMURAI was 40.7% in the 200-mg group and 29.5% in controls. The rate of patients free of MBS in SPARTAN was 48.7% in the 200-mg group and 33.5% in controls. For both end points, the investigators also found significant differences for other lasmiditan dose groups, compared with placebo.

The most frequently reported TEAEs with lasmiditan (ie, those occurring with a frequency of 2% or greater and at a rate greater than that among controls) after the first dose were dizziness, paresthesia, somnolence, fatigue, nausea, and lethargy. Most events were mild to moderate in severity.

Suggested Reading

Färkkilä M, Diener HC, Géraud G, et al. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012;11(5):405-413.

SAN FRANCISCO—Lasmiditan may provide pain freedom in the acute treatment of migraine, according to data described at the 60th Annual Scientific Meeting of the American Headache Society. The treatment also may alleviate a patient’s most bothersome symptom (MBS).

Lasmiditan is a novel, centrally acting serotonin (5-HT_1F) agonist that has no vasoconstrictive effect. Linda A. Wietecha, BSN, MS, Medical Advisor for Migraine and Headache Disorders at Eli Lilly and Company in Indianapolis, and colleagues conducted two pivotal phase III studies of lasmiditan to evaluate its efficacy and safety as an acute treatment of migraine.

The two trials, SAMURAI and SPARTAN, were randomized, double-blinded, and placebo-controlled. Eligible participants had a Migraine Disability Assessment Score of 11 or higher (indicating moderate disability) and three to eight migraine attacks per month. The researchers randomized patients to a first dose of treatment, which was taken within four hours of onset of a migraine with moderate or worse severity that was not improving. In the SAMURAI trial, patients were randomized in equal groups to 200 mg of lasmiditan, 100 mg of lasmiditan, or placebo. In the SPARTAN study, patients were randomized in equal groups to 200 mg of lasmiditan, 100 mg of lasmiditan, 50 mg of lasmiditan, or placebo.

For rescue or recurrence treatment, patients took a randomly assigned second dose of the previously assigned lasmiditan dose or placebo. The primary and key secondary analyses compared the proportions of patients in the lasmiditan 200-mg group with that in the placebo group who were free of headache pain and free of their MBS at two hours after the first dose. Treatment-emergent adverse events (TEAEs) were used to assess safety. The investigators performed logistic regression to make comparisons.

At two hours after the first dose, significantly greater proportions of patients taking 200 mg of lasmiditan were free of headache pain and free of MBS, compared with controls. In SAMURAI, the rate of headache pain freedom was 32.2% in the 200-mg group and 15.3% among controls. In SPARTAN, the rate of headache pain freedom was 38.8% in the 200-mg group and 21.3% in controls. The rate of patients free of MBS in SAMURAI was 40.7% in the 200-mg group and 29.5% in controls. The rate of patients free of MBS in SPARTAN was 48.7% in the 200-mg group and 33.5% in controls. For both end points, the investigators also found significant differences for other lasmiditan dose groups, compared with placebo.

The most frequently reported TEAEs with lasmiditan (ie, those occurring with a frequency of 2% or greater and at a rate greater than that among controls) after the first dose were dizziness, paresthesia, somnolence, fatigue, nausea, and lethargy. Most events were mild to moderate in severity.

Suggested Reading

Färkkilä M, Diener HC, Géraud G, et al. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012;11(5):405-413.

SAN FRANCISCO—Among patients with acute migraine, significant and durable clinical effects were seen with a single dose of rimegepant across multiple outcome measures, including pain freedom, freedom from most bothersome symptom, pain relief, and recovery of normal function, according to data presented at the 60th Annual Scientific Meeting of the American Headache Society. Rimegepant (75 mg oral tablet) demonstrated favorable tolerability and safety, including a liver safety profile, similar to placebo. “These clinically meaningful results complement the benefits seen in an identical phase III study and a previous phase IIb study,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. “Rimegepant may ultimately offer patients a novel approach for the acute treatment of migraine.”

Dr. Lipton and colleagues conducted a double-blind, randomized, placebo-controlled trial to compare the efficacy, safety, and tolerability of the calcitonin gene-related peptide (CGRP) receptor antagonist rimegepant (75 mg oral tablet) with placebo in the acute treatment of migraine in adults.

SAN FRANCISCO—Among patients with acute migraine, significant and durable clinical effects were seen with a single dose of rimegepant across multiple outcome measures, including pain freedom, freedom from most bothersome symptom, pain relief, and recovery of normal function, according to data presented at the 60th Annual Scientific Meeting of the American Headache Society. Rimegepant (75 mg oral tablet) demonstrated favorable tolerability and safety, including a liver safety profile, similar to placebo. “These clinically meaningful results complement the benefits seen in an identical phase III study and a previous phase IIb study,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. “Rimegepant may ultimately offer patients a novel approach for the acute treatment of migraine.”

Dr. Lipton and colleagues conducted a double-blind, randomized, placebo-controlled trial to compare the efficacy, safety, and tolerability of the calcitonin gene-related peptide (CGRP) receptor antagonist rimegepant (75 mg oral tablet) with placebo in the acute treatment of migraine in adults.

SAN FRANCISCO—Among patients with acute migraine, significant and durable clinical effects were seen with a single dose of rimegepant across multiple outcome measures, including pain freedom, freedom from most bothersome symptom, pain relief, and recovery of normal function, according to data presented at the 60th Annual Scientific Meeting of the American Headache Society. Rimegepant (75 mg oral tablet) demonstrated favorable tolerability and safety, including a liver safety profile, similar to placebo. “These clinically meaningful results complement the benefits seen in an identical phase III study and a previous phase IIb study,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. “Rimegepant may ultimately offer patients a novel approach for the acute treatment of migraine.”

Dr. Lipton and colleagues conducted a double-blind, randomized, placebo-controlled trial to compare the efficacy, safety, and tolerability of the calcitonin gene-related peptide (CGRP) receptor antagonist rimegepant (75 mg oral tablet) with placebo in the acute treatment of migraine in adults.