Headache & Migraine

The Food and Drug Administration has approved ubrogepant (Ubrelvy, Allergan) for the acute treatment of migraine with or without aura in adults.

Olivier Le Moal/Getty Images

Ubrogepant is the first drug in the class of oral calcitonin gene–related peptide receptor antagonists approved for the acute treatment of migraine. It is approved in two dose strengths (50 mg and 100 mg).

The drug is not indicated, however, for the preventive treatment of migraine.

“Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.,” Billy Dunn, MD, acting director of the office of neuroscience in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

Ubrogepant represents “an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication. The FDA is pleased to approve a novel treatment for patients suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies,” added Dr. Dunn.

The safety and efficacy of ubrogepant for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials (ACHIEVE I and ACHIEVE II). In total, 1,439 adults with a history of migraine, with and without aura, received ubrogepant to treat an ongoing migraine.

“Both 50-mg and 100-mg dose strengths demonstrated significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at 2 hours, compared with placebo,” Allergan said in a news release announcing approval.

The most common side effects reported by patients in the clinical trials were nausea, tiredness, and dry mouth. Ubrogepant is contraindicated for coadministration with strong CYP3A4 inhibitors.

The company expects to have ubrogepant available in the first quarter of 2020.

A version of this story originally appeared on Medscape.com.

The Food and Drug Administration has approved ubrogepant (Ubrelvy, Allergan) for the acute treatment of migraine with or without aura in adults.

Olivier Le Moal/Getty Images

Ubrogepant is the first drug in the class of oral calcitonin gene–related peptide receptor antagonists approved for the acute treatment of migraine. It is approved in two dose strengths (50 mg and 100 mg).

The drug is not indicated, however, for the preventive treatment of migraine.

“Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.,” Billy Dunn, MD, acting director of the office of neuroscience in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

Ubrogepant represents “an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication. The FDA is pleased to approve a novel treatment for patients suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies,” added Dr. Dunn.

The safety and efficacy of ubrogepant for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials (ACHIEVE I and ACHIEVE II). In total, 1,439 adults with a history of migraine, with and without aura, received ubrogepant to treat an ongoing migraine.

“Both 50-mg and 100-mg dose strengths demonstrated significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at 2 hours, compared with placebo,” Allergan said in a news release announcing approval.

The most common side effects reported by patients in the clinical trials were nausea, tiredness, and dry mouth. Ubrogepant is contraindicated for coadministration with strong CYP3A4 inhibitors.

The company expects to have ubrogepant available in the first quarter of 2020.

A version of this story originally appeared on Medscape.com.

The Food and Drug Administration has approved ubrogepant (Ubrelvy, Allergan) for the acute treatment of migraine with or without aura in adults.

Olivier Le Moal/Getty Images

Ubrogepant is the first drug in the class of oral calcitonin gene–related peptide receptor antagonists approved for the acute treatment of migraine. It is approved in two dose strengths (50 mg and 100 mg).

The drug is not indicated, however, for the preventive treatment of migraine.

“Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.,” Billy Dunn, MD, acting director of the office of neuroscience in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

Ubrogepant represents “an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication. The FDA is pleased to approve a novel treatment for patients suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies,” added Dr. Dunn.

The safety and efficacy of ubrogepant for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials (ACHIEVE I and ACHIEVE II). In total, 1,439 adults with a history of migraine, with and without aura, received ubrogepant to treat an ongoing migraine.

“Both 50-mg and 100-mg dose strengths demonstrated significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at 2 hours, compared with placebo,” Allergan said in a news release announcing approval.

The most common side effects reported by patients in the clinical trials were nausea, tiredness, and dry mouth. Ubrogepant is contraindicated for coadministration with strong CYP3A4 inhibitors.

The company expects to have ubrogepant available in the first quarter of 2020.

A version of this story originally appeared on Medscape.com.

About 20% of patients who receive tablets containing 50 mg or 100 mg of ubrogepant for the acute treatment of migraine are pain free 2 hours later, compared with 12% of patients who receive placebo, according to phase 3 trial results published Dec. 4 in the New England Journal of Medicine. In addition, about 38% of patients who receive ubrogepant no longer have their most bothersome migraine-associated symptom, such as photophobia, phonophobia, or nausea, at 2 hours, compared with 28% of patients who receive placebo, said David W. Dodick, MD, and colleagues.

Dr. Dodick, professor of neurology at the Mayo Clinic in Phoenix, and his coauthors described efficacy and safety results from the ACHIEVE I trial. Another phase 3 study of ubrogepant, ACHIEVE II, was published in JAMA in November. That trial evaluated 25- and 50-mg doses of ubrogepant versus placebo and found rates of pain freedom and absence of the most bothersome symptom in the placebo and active treatment arms that were similar to those in ACHIEVE I.

Assessing a gepant for acute migraine treatment

Ubrogepant is an oral calcitonin gene–related peptide (CGRP) receptor antagonist. Allergan, the company developing the drug, has said it expects the Food and Drug Administration to decide in December whether to approve the drug.

To compare ubrogepant 50 mg, ubrogepant 100 mg, and placebo for the acute treatment of migraine, investigators conducted the randomized ACHIEVE I trial. Researchers enrolled 1,672 adults with migraine with or without aura. They excluded patients with clinically significant cardiovascular or cerebrovascular disease. During the trial, patients treated a single migraine attack, and they had the option to take a second dose. In all, 1,436 participants took an initial dose. Patients had an average age of 40.5 years, about 88% were women, and 82% were white.

In ACHIEVE I, the most common adverse events within 48 hours of treatment were nausea, somnolence, and dry mouth, and these events occurred more frequently in the 100-mg–dose group, Dr. Dodick and colleagues reported. Among patients who received ubrogepant, serious adverse events more than 48 hours after treatment but within 30 days of treatment included appendicitis, spontaneous abortion, pericardial effusion, and seizure. No serious adverse events occurred in the placebo group.

The authors noted that, “there was no active comparator and no evaluation of consistency of effect across multiple migraine attacks; therefore it is not possible to determine whether the drug is more or less effective than standard therapies or consistently effective with repeated use.” In addition, “safety and side-effect data from this trial were based on evaluation of a single attack, and therefore safety after repeated use cannot be inferred; an extension trial has assessed the long-term safety of ubrogepant,” they said.

The present trial was performed well, commented Alan M. Rapoport, MD. “The coprimary endpoints of pain freedom and most bothersome symptom freedom, both at 2 hours after dosing, were statistically superior for both doses of ubrogepant versus placebo,” he said. “Some of the secondary endpoints, such as pain relief at 2 hours post dose and sustained pain relief from 2 to 24 hours, were statistically better than placebo.”

“Based on this data, I suspect that the FDA would approve this gepant after appropriate safety data,” said Dr. Rapoport, clinical professor of neurology at the University of California, Los Angeles and editor-in-chief of Neurology Reviews. “Many more patients need to take this drug before we can be sure it is safe and effective.”

The CGRP therapeutic landscape

“Other gepants have been shown to be effective, although some have caused a degree of liver toxicity,” said Dr. Rapoport. “Blocking the effect of CGRP on the migraine peripheral nervous system, in this case by preventing the ligand from docking at its receptor by administering an oral CGRP receptor blocker, appears to be effective.” Researchers are studying another oral gepant for similar approval, he added.

Ubrogepant stands to join other treatments targeting CGRP.

“There are currently three, and soon to be four, injectable monoclonal antibodies against CGRP functionality, which are preventive, not acute-care drugs,” Dr. Rapoport said. “The first released was a subcutaneous injection of a CGRP receptor blocker, and the other two are subcutaneous injections of CGRP ligand blockers. The last drug will be an intravenous infusion of a ligand blocker. These recently approved migraine treatments have greatly improved the lives of many of our patients, even when other preventives have failed. I expect ubrogepant and other gepants will do the same for the acute care of migraine.”

Allergan funded the trials of ubrogepant, and some of the authors are Allergan employees and stockholders. Dr. Dodick reported consulting fees and advisory board fees from Allergan and various pharmaceutical companies.

[email protected]

SOURCE: Dodick DW et al. N Engl J Med. 2019;381(23):2230-41. doi: 10.1056/NEJMoa1813049.

About 20% of patients who receive tablets containing 50 mg or 100 mg of ubrogepant for the acute treatment of migraine are pain free 2 hours later, compared with 12% of patients who receive placebo, according to phase 3 trial results published Dec. 4 in the New England Journal of Medicine. In addition, about 38% of patients who receive ubrogepant no longer have their most bothersome migraine-associated symptom, such as photophobia, phonophobia, or nausea, at 2 hours, compared with 28% of patients who receive placebo, said David W. Dodick, MD, and colleagues.

Dr. Dodick, professor of neurology at the Mayo Clinic in Phoenix, and his coauthors described efficacy and safety results from the ACHIEVE I trial. Another phase 3 study of ubrogepant, ACHIEVE II, was published in JAMA in November. That trial evaluated 25- and 50-mg doses of ubrogepant versus placebo and found rates of pain freedom and absence of the most bothersome symptom in the placebo and active treatment arms that were similar to those in ACHIEVE I.

Assessing a gepant for acute migraine treatment

Ubrogepant is an oral calcitonin gene–related peptide (CGRP) receptor antagonist. Allergan, the company developing the drug, has said it expects the Food and Drug Administration to decide in December whether to approve the drug.

To compare ubrogepant 50 mg, ubrogepant 100 mg, and placebo for the acute treatment of migraine, investigators conducted the randomized ACHIEVE I trial. Researchers enrolled 1,672 adults with migraine with or without aura. They excluded patients with clinically significant cardiovascular or cerebrovascular disease. During the trial, patients treated a single migraine attack, and they had the option to take a second dose. In all, 1,436 participants took an initial dose. Patients had an average age of 40.5 years, about 88% were women, and 82% were white.

In ACHIEVE I, the most common adverse events within 48 hours of treatment were nausea, somnolence, and dry mouth, and these events occurred more frequently in the 100-mg–dose group, Dr. Dodick and colleagues reported. Among patients who received ubrogepant, serious adverse events more than 48 hours after treatment but within 30 days of treatment included appendicitis, spontaneous abortion, pericardial effusion, and seizure. No serious adverse events occurred in the placebo group.

The authors noted that, “there was no active comparator and no evaluation of consistency of effect across multiple migraine attacks; therefore it is not possible to determine whether the drug is more or less effective than standard therapies or consistently effective with repeated use.” In addition, “safety and side-effect data from this trial were based on evaluation of a single attack, and therefore safety after repeated use cannot be inferred; an extension trial has assessed the long-term safety of ubrogepant,” they said.

The present trial was performed well, commented Alan M. Rapoport, MD. “The coprimary endpoints of pain freedom and most bothersome symptom freedom, both at 2 hours after dosing, were statistically superior for both doses of ubrogepant versus placebo,” he said. “Some of the secondary endpoints, such as pain relief at 2 hours post dose and sustained pain relief from 2 to 24 hours, were statistically better than placebo.”

“Based on this data, I suspect that the FDA would approve this gepant after appropriate safety data,” said Dr. Rapoport, clinical professor of neurology at the University of California, Los Angeles and editor-in-chief of Neurology Reviews. “Many more patients need to take this drug before we can be sure it is safe and effective.”

The CGRP therapeutic landscape

“Other gepants have been shown to be effective, although some have caused a degree of liver toxicity,” said Dr. Rapoport. “Blocking the effect of CGRP on the migraine peripheral nervous system, in this case by preventing the ligand from docking at its receptor by administering an oral CGRP receptor blocker, appears to be effective.” Researchers are studying another oral gepant for similar approval, he added.

Ubrogepant stands to join other treatments targeting CGRP.

“There are currently three, and soon to be four, injectable monoclonal antibodies against CGRP functionality, which are preventive, not acute-care drugs,” Dr. Rapoport said. “The first released was a subcutaneous injection of a CGRP receptor blocker, and the other two are subcutaneous injections of CGRP ligand blockers. The last drug will be an intravenous infusion of a ligand blocker. These recently approved migraine treatments have greatly improved the lives of many of our patients, even when other preventives have failed. I expect ubrogepant and other gepants will do the same for the acute care of migraine.”

Allergan funded the trials of ubrogepant, and some of the authors are Allergan employees and stockholders. Dr. Dodick reported consulting fees and advisory board fees from Allergan and various pharmaceutical companies.

[email protected]

SOURCE: Dodick DW et al. N Engl J Med. 2019;381(23):2230-41. doi: 10.1056/NEJMoa1813049.

About 20% of patients who receive tablets containing 50 mg or 100 mg of ubrogepant for the acute treatment of migraine are pain free 2 hours later, compared with 12% of patients who receive placebo, according to phase 3 trial results published Dec. 4 in the New England Journal of Medicine. In addition, about 38% of patients who receive ubrogepant no longer have their most bothersome migraine-associated symptom, such as photophobia, phonophobia, or nausea, at 2 hours, compared with 28% of patients who receive placebo, said David W. Dodick, MD, and colleagues.

Dr. Dodick, professor of neurology at the Mayo Clinic in Phoenix, and his coauthors described efficacy and safety results from the ACHIEVE I trial. Another phase 3 study of ubrogepant, ACHIEVE II, was published in JAMA in November. That trial evaluated 25- and 50-mg doses of ubrogepant versus placebo and found rates of pain freedom and absence of the most bothersome symptom in the placebo and active treatment arms that were similar to those in ACHIEVE I.

Assessing a gepant for acute migraine treatment

Ubrogepant is an oral calcitonin gene–related peptide (CGRP) receptor antagonist. Allergan, the company developing the drug, has said it expects the Food and Drug Administration to decide in December whether to approve the drug.

To compare ubrogepant 50 mg, ubrogepant 100 mg, and placebo for the acute treatment of migraine, investigators conducted the randomized ACHIEVE I trial. Researchers enrolled 1,672 adults with migraine with or without aura. They excluded patients with clinically significant cardiovascular or cerebrovascular disease. During the trial, patients treated a single migraine attack, and they had the option to take a second dose. In all, 1,436 participants took an initial dose. Patients had an average age of 40.5 years, about 88% were women, and 82% were white.

In ACHIEVE I, the most common adverse events within 48 hours of treatment were nausea, somnolence, and dry mouth, and these events occurred more frequently in the 100-mg–dose group, Dr. Dodick and colleagues reported. Among patients who received ubrogepant, serious adverse events more than 48 hours after treatment but within 30 days of treatment included appendicitis, spontaneous abortion, pericardial effusion, and seizure. No serious adverse events occurred in the placebo group.

The authors noted that, “there was no active comparator and no evaluation of consistency of effect across multiple migraine attacks; therefore it is not possible to determine whether the drug is more or less effective than standard therapies or consistently effective with repeated use.” In addition, “safety and side-effect data from this trial were based on evaluation of a single attack, and therefore safety after repeated use cannot be inferred; an extension trial has assessed the long-term safety of ubrogepant,” they said.

The present trial was performed well, commented Alan M. Rapoport, MD. “The coprimary endpoints of pain freedom and most bothersome symptom freedom, both at 2 hours after dosing, were statistically superior for both doses of ubrogepant versus placebo,” he said. “Some of the secondary endpoints, such as pain relief at 2 hours post dose and sustained pain relief from 2 to 24 hours, were statistically better than placebo.”

“Based on this data, I suspect that the FDA would approve this gepant after appropriate safety data,” said Dr. Rapoport, clinical professor of neurology at the University of California, Los Angeles and editor-in-chief of Neurology Reviews. “Many more patients need to take this drug before we can be sure it is safe and effective.”

The CGRP therapeutic landscape

“Other gepants have been shown to be effective, although some have caused a degree of liver toxicity,” said Dr. Rapoport. “Blocking the effect of CGRP on the migraine peripheral nervous system, in this case by preventing the ligand from docking at its receptor by administering an oral CGRP receptor blocker, appears to be effective.” Researchers are studying another oral gepant for similar approval, he added.

Ubrogepant stands to join other treatments targeting CGRP.

“There are currently three, and soon to be four, injectable monoclonal antibodies against CGRP functionality, which are preventive, not acute-care drugs,” Dr. Rapoport said. “The first released was a subcutaneous injection of a CGRP receptor blocker, and the other two are subcutaneous injections of CGRP ligand blockers. The last drug will be an intravenous infusion of a ligand blocker. These recently approved migraine treatments have greatly improved the lives of many of our patients, even when other preventives have failed. I expect ubrogepant and other gepants will do the same for the acute care of migraine.”

Allergan funded the trials of ubrogepant, and some of the authors are Allergan employees and stockholders. Dr. Dodick reported consulting fees and advisory board fees from Allergan and various pharmaceutical companies.

[email protected]

SOURCE: Dodick DW et al. N Engl J Med. 2019;381(23):2230-41. doi: 10.1056/NEJMoa1813049.

CHARLOTTE, N.C. – Most children who undergo hemispherectomy for severe, intractable epilepsy report headaches after the procedure, according to a study presented at the annual meeting of the Child Neurology Society. Patients with headache before hemispherectomy may be at risk of increased headache frequency after the procedure. The most common type of headache reported is nonmigrainous headache.

“We recommend that hemispherectomy patients be evaluated and followed closely postoperatively and questioned regarding the presence of headache,” said William Bingaman, MD, vice-chair of the neurological institute and head of the section of epilepsy surgery at the Cleveland Clinic, and colleagues. “Patients should be assessed and treated quickly to decrease prolonged pain and suffering and increase function.”

The two main types of hemispherectomy are anatomical and functional. Anatomical hemispherectomy entails the removal of a large amount of brain mass. Functional hemispherectomy entails the removal of a smaller amount of brain mass, as well as the disconnection of the brain’s hemispheres. Most patients are seizure free or have reduced seizure frequency after hemispherectomy. Other common postoperative outcomes include changes in behavior, cognition, motor function, and speech. Many studies have explored these outcomes, but few have examined the frequency of postoperative headache in children who undergo hemispherectomy.

Dr. Bingaman and colleagues retrospectively reviewed the charts of 74 children who underwent hemispherectomy at the Cleveland Clinic during the previous 5 years. They excluded 14 patients who were too young to respond for the analysis. The investigators sent the remaining 60 patients an informative letter and followed up with a 10-minute phone questionnaire about patients’ postoperative headache symptoms.

Twenty-two (36.7%) eligible patients completed the questionnaire. Thirty-eight patients could not be reached or declined to participate. Half of the 22 respondents were male. Participants’ median age at surgery was 6.5 years. The most common types of hemispherectomy were left functional (50%) and right functional (31.8%).

Nine (39.1%) of the 22 respondents had headache before surgery, and seven (31.8%) reported a family history of headache. In all, 19 (86.4%) patients had headache after surgery, and 10 (45.5%) had headaches that began after the surgery. Of the nine patients with preoperative headache, six (66.6%) had an increase in headache frequency after surgery, two (22.2%) reported no change, and one (11.1%) had decreased headache frequency. The most common type of headache reported was tension-type headache, and migraine was the second most common.

“The cause of any posthemispherectomy headache has thus far only been attributed to hydrocephalus,” wrote Dr. Bingaman and colleagues. “The tendency of headache to worsen following stresses such as illness, stroke, trauma, etc. has been studied extensively. The pathophysiology of posthemispherectomy headache can be investigated further by classifying hemispherectomy as a type of trauma or injury, which would explain the development of postoperative headache. Previous studies on posttraumatic headache have ascribed these headaches to neuroinflammation following the injury. Additionally, posthemispherectomy headache could also be due to the buildup of debris and fluid following the operation. Future hemispherectomy patients should be treated prophylactically for headache.”

The authors did not report funding for their study or declare any disclosures.

[email protected]

SOURCE: Pandit I et al. CNS 2019. Abstract 99.

CHARLOTTE, N.C. – Most children who undergo hemispherectomy for severe, intractable epilepsy report headaches after the procedure, according to a study presented at the annual meeting of the Child Neurology Society. Patients with headache before hemispherectomy may be at risk of increased headache frequency after the procedure. The most common type of headache reported is nonmigrainous headache.

“We recommend that hemispherectomy patients be evaluated and followed closely postoperatively and questioned regarding the presence of headache,” said William Bingaman, MD, vice-chair of the neurological institute and head of the section of epilepsy surgery at the Cleveland Clinic, and colleagues. “Patients should be assessed and treated quickly to decrease prolonged pain and suffering and increase function.”

The two main types of hemispherectomy are anatomical and functional. Anatomical hemispherectomy entails the removal of a large amount of brain mass. Functional hemispherectomy entails the removal of a smaller amount of brain mass, as well as the disconnection of the brain’s hemispheres. Most patients are seizure free or have reduced seizure frequency after hemispherectomy. Other common postoperative outcomes include changes in behavior, cognition, motor function, and speech. Many studies have explored these outcomes, but few have examined the frequency of postoperative headache in children who undergo hemispherectomy.

Dr. Bingaman and colleagues retrospectively reviewed the charts of 74 children who underwent hemispherectomy at the Cleveland Clinic during the previous 5 years. They excluded 14 patients who were too young to respond for the analysis. The investigators sent the remaining 60 patients an informative letter and followed up with a 10-minute phone questionnaire about patients’ postoperative headache symptoms.

Twenty-two (36.7%) eligible patients completed the questionnaire. Thirty-eight patients could not be reached or declined to participate. Half of the 22 respondents were male. Participants’ median age at surgery was 6.5 years. The most common types of hemispherectomy were left functional (50%) and right functional (31.8%).

Nine (39.1%) of the 22 respondents had headache before surgery, and seven (31.8%) reported a family history of headache. In all, 19 (86.4%) patients had headache after surgery, and 10 (45.5%) had headaches that began after the surgery. Of the nine patients with preoperative headache, six (66.6%) had an increase in headache frequency after surgery, two (22.2%) reported no change, and one (11.1%) had decreased headache frequency. The most common type of headache reported was tension-type headache, and migraine was the second most common.

“The cause of any posthemispherectomy headache has thus far only been attributed to hydrocephalus,” wrote Dr. Bingaman and colleagues. “The tendency of headache to worsen following stresses such as illness, stroke, trauma, etc. has been studied extensively. The pathophysiology of posthemispherectomy headache can be investigated further by classifying hemispherectomy as a type of trauma or injury, which would explain the development of postoperative headache. Previous studies on posttraumatic headache have ascribed these headaches to neuroinflammation following the injury. Additionally, posthemispherectomy headache could also be due to the buildup of debris and fluid following the operation. Future hemispherectomy patients should be treated prophylactically for headache.”

The authors did not report funding for their study or declare any disclosures.

[email protected]

SOURCE: Pandit I et al. CNS 2019. Abstract 99.

CHARLOTTE, N.C. – Most children who undergo hemispherectomy for severe, intractable epilepsy report headaches after the procedure, according to a study presented at the annual meeting of the Child Neurology Society. Patients with headache before hemispherectomy may be at risk of increased headache frequency after the procedure. The most common type of headache reported is nonmigrainous headache.

“We recommend that hemispherectomy patients be evaluated and followed closely postoperatively and questioned regarding the presence of headache,” said William Bingaman, MD, vice-chair of the neurological institute and head of the section of epilepsy surgery at the Cleveland Clinic, and colleagues. “Patients should be assessed and treated quickly to decrease prolonged pain and suffering and increase function.”

The two main types of hemispherectomy are anatomical and functional. Anatomical hemispherectomy entails the removal of a large amount of brain mass. Functional hemispherectomy entails the removal of a smaller amount of brain mass, as well as the disconnection of the brain’s hemispheres. Most patients are seizure free or have reduced seizure frequency after hemispherectomy. Other common postoperative outcomes include changes in behavior, cognition, motor function, and speech. Many studies have explored these outcomes, but few have examined the frequency of postoperative headache in children who undergo hemispherectomy.

Dr. Bingaman and colleagues retrospectively reviewed the charts of 74 children who underwent hemispherectomy at the Cleveland Clinic during the previous 5 years. They excluded 14 patients who were too young to respond for the analysis. The investigators sent the remaining 60 patients an informative letter and followed up with a 10-minute phone questionnaire about patients’ postoperative headache symptoms.

Twenty-two (36.7%) eligible patients completed the questionnaire. Thirty-eight patients could not be reached or declined to participate. Half of the 22 respondents were male. Participants’ median age at surgery was 6.5 years. The most common types of hemispherectomy were left functional (50%) and right functional (31.8%).

Nine (39.1%) of the 22 respondents had headache before surgery, and seven (31.8%) reported a family history of headache. In all, 19 (86.4%) patients had headache after surgery, and 10 (45.5%) had headaches that began after the surgery. Of the nine patients with preoperative headache, six (66.6%) had an increase in headache frequency after surgery, two (22.2%) reported no change, and one (11.1%) had decreased headache frequency. The most common type of headache reported was tension-type headache, and migraine was the second most common.

“The cause of any posthemispherectomy headache has thus far only been attributed to hydrocephalus,” wrote Dr. Bingaman and colleagues. “The tendency of headache to worsen following stresses such as illness, stroke, trauma, etc. has been studied extensively. The pathophysiology of posthemispherectomy headache can be investigated further by classifying hemispherectomy as a type of trauma or injury, which would explain the development of postoperative headache. Previous studies on posttraumatic headache have ascribed these headaches to neuroinflammation following the injury. Additionally, posthemispherectomy headache could also be due to the buildup of debris and fluid following the operation. Future hemispherectomy patients should be treated prophylactically for headache.”

The authors did not report funding for their study or declare any disclosures.

[email protected]

SOURCE: Pandit I et al. CNS 2019. Abstract 99.

Key clinical point: The 12-week injection cycle of Onabotulinumtoxin A (OnabotA) may need to be reconsidered.

Major finding: The study of 98 patients and 471 treatment cycles found that 43 patients experienced one or more wearing-off-effect (WOE) events (worsening headaches and neck pain). Of those patients, 24 reported 1 WOE event and 19 patients reported 2 or more WOEs. Almost 32% of patients used abortive therapy to manage their WOEs.

Study details: This was a retrospective review of patients with worsening headache variables and neck pain who received OnabotA for their chronic migraine in treatment cycles.

Disclosures: Dr. Khan received honorarium for Depomed, Inc. and Promius Pharma while conducting the study.

Citation: Khan FA, et al. Headache. 2019 Nov 22. doi: 10.1111/head.13713. [Epub ahead of print].

Key clinical point: The 12-week injection cycle of Onabotulinumtoxin A (OnabotA) may need to be reconsidered.

Major finding: The study of 98 patients and 471 treatment cycles found that 43 patients experienced one or more wearing-off-effect (WOE) events (worsening headaches and neck pain). Of those patients, 24 reported 1 WOE event and 19 patients reported 2 or more WOEs. Almost 32% of patients used abortive therapy to manage their WOEs.

Study details: This was a retrospective review of patients with worsening headache variables and neck pain who received OnabotA for their chronic migraine in treatment cycles.

Disclosures: Dr. Khan received honorarium for Depomed, Inc. and Promius Pharma while conducting the study.

Citation: Khan FA, et al. Headache. 2019 Nov 22. doi: 10.1111/head.13713. [Epub ahead of print].

Key clinical point: The 12-week injection cycle of Onabotulinumtoxin A (OnabotA) may need to be reconsidered.

Major finding: The study of 98 patients and 471 treatment cycles found that 43 patients experienced one or more wearing-off-effect (WOE) events (worsening headaches and neck pain). Of those patients, 24 reported 1 WOE event and 19 patients reported 2 or more WOEs. Almost 32% of patients used abortive therapy to manage their WOEs.

Study details: This was a retrospective review of patients with worsening headache variables and neck pain who received OnabotA for their chronic migraine in treatment cycles.

Disclosures: Dr. Khan received honorarium for Depomed, Inc. and Promius Pharma while conducting the study.

Citation: Khan FA, et al. Headache. 2019 Nov 22. doi: 10.1111/head.13713. [Epub ahead of print].

Key clinical point: Onabotulinumtoxin A (OnabotA) may decrease migraine days by 50% or more.

Major finding: Of 112 patients with chronic migraine (100 female), 96 responded positively to OnabotA, resulting in decreased migraine days by at least 50%. Having a dependent personality trait was linked to treatment nonresponse.

Study details: This was a case-control observational study of chronic migraine patients that received two or more treatment cycles of OnabotA.

Disclosures: None.

Citation: Gonzalez-Martinez A, et al. Headache. 2019 Nov 6. doi: 10.1111/head.13693. [Epub ahead of print].

Key clinical point: Onabotulinumtoxin A (OnabotA) may decrease migraine days by 50% or more.

Major finding: Of 112 patients with chronic migraine (100 female), 96 responded positively to OnabotA, resulting in decreased migraine days by at least 50%. Having a dependent personality trait was linked to treatment nonresponse.

Study details: This was a case-control observational study of chronic migraine patients that received two or more treatment cycles of OnabotA.

Disclosures: None.

Citation: Gonzalez-Martinez A, et al. Headache. 2019 Nov 6. doi: 10.1111/head.13693. [Epub ahead of print].

Key clinical point: Onabotulinumtoxin A (OnabotA) may decrease migraine days by 50% or more.

Major finding: Of 112 patients with chronic migraine (100 female), 96 responded positively to OnabotA, resulting in decreased migraine days by at least 50%. Having a dependent personality trait was linked to treatment nonresponse.

Study details: This was a case-control observational study of chronic migraine patients that received two or more treatment cycles of OnabotA.

Disclosures: None.

Citation: Gonzalez-Martinez A, et al. Headache. 2019 Nov 6. doi: 10.1111/head.13693. [Epub ahead of print].

Key clinical point: Vitamin D supplementation may decrease the frequency, severity, and duration of migraines.

Major finding: Significantly lower 25 (OH)-vitamin D levels were found in patients with migraine, compared with healthy controls. Migraine patients with low vitamin D levels had a higher incidence of aura, phonophobia/photophobia, autonomic manifestations, allodynia, and medication resistance.

Study details: This was a case-control study of 40 patients with migraine, compared with 40 healthy control patients. Patient history was taken including headache characteristics, MIGSEV, and HIT-6 scores. Each patient’s serum 25 (OH)-vitamin D level was measured.

Disclosures: None.

Citation: Hussein M, et al. J Pain Res. 2019 Aug 20;12:2529-36. doi: 10.2147/JPR.S216314. eCollection 2019.

Key clinical point: Vitamin D supplementation may decrease the frequency, severity, and duration of migraines.

Major finding: Significantly lower 25 (OH)-vitamin D levels were found in patients with migraine, compared with healthy controls. Migraine patients with low vitamin D levels had a higher incidence of aura, phonophobia/photophobia, autonomic manifestations, allodynia, and medication resistance.

Study details: This was a case-control study of 40 patients with migraine, compared with 40 healthy control patients. Patient history was taken including headache characteristics, MIGSEV, and HIT-6 scores. Each patient’s serum 25 (OH)-vitamin D level was measured.

Disclosures: None.

Citation: Hussein M, et al. J Pain Res. 2019 Aug 20;12:2529-36. doi: 10.2147/JPR.S216314. eCollection 2019.

Key clinical point: Vitamin D supplementation may decrease the frequency, severity, and duration of migraines.

Major finding: Significantly lower 25 (OH)-vitamin D levels were found in patients with migraine, compared with healthy controls. Migraine patients with low vitamin D levels had a higher incidence of aura, phonophobia/photophobia, autonomic manifestations, allodynia, and medication resistance.

Study details: This was a case-control study of 40 patients with migraine, compared with 40 healthy control patients. Patient history was taken including headache characteristics, MIGSEV, and HIT-6 scores. Each patient’s serum 25 (OH)-vitamin D level was measured.

Disclosures: None.

Citation: Hussein M, et al. J Pain Res. 2019 Aug 20;12:2529-36. doi: 10.2147/JPR.S216314. eCollection 2019.

Episodic visual snow was tied to migraine attacks in a case series of three adults who denied any visual snow outside of the migraines, based on data collected at an outpatient headache center.

Visual snow, a condition in which patients experience visual distortion of tiny, flickering dots resembling analog television static, is often a comorbid condition in migraine patients with and without aura. However, “to our knowledge, this is the first report of patients with an episodic form of visual snow strictly occurring with migraine attacks,” wrote Julius Hodak, MD, of the University of Bern (Switzerland) and colleagues.

In a research letter published in JAMA Neurology, the investigators described 3 adults with histories of migraine but no aura who presented to a tertiary headache center between January 2016 and December 2017, in addition to 1,934 adults with migraine but no visual snow. The three patients initially presented with headaches, and neurologic and MRI results were normal.

Two patients experienced black and white episodic visual snow and one experienced black and yellow visual snow. In one patient, visual snow occurred for less than 2 minutes before and during a migraine attack. The other two patients experienced visual snow during the entire migraine attack.

Based on these patients, the researchers proposed distinguishing episodic visual snow from the distinct disorder of visual snow syndrome, in which patients experience continuous visual snow and other visual symptoms.

In addition, the cases were notable because of the lack of aura in the patients, the researchers wrote.

“In clinical practice, a detailed history in patients reporting visual flickering is therefore necessary to differentiate aura from [episodic visual snow],” they added, because an aura diagnosis would affect patient guidance on contraception use or the timing of triptans.

Dr. Hodak had no financial conflicts to disclose. The study was supported by Deutsche Migräne-und Kopfschmerzgesellschaft, Eye on Vision Foundation, and Baasch-Medicus Foundation.

SOURCE: Hodak J et al. JAMA Neurol. 2019 Nov 25. doi: 10.1001/jamaneurol.2019.4050.

Episodic visual snow was tied to migraine attacks in a case series of three adults who denied any visual snow outside of the migraines, based on data collected at an outpatient headache center.

Visual snow, a condition in which patients experience visual distortion of tiny, flickering dots resembling analog television static, is often a comorbid condition in migraine patients with and without aura. However, “to our knowledge, this is the first report of patients with an episodic form of visual snow strictly occurring with migraine attacks,” wrote Julius Hodak, MD, of the University of Bern (Switzerland) and colleagues.

In a research letter published in JAMA Neurology, the investigators described 3 adults with histories of migraine but no aura who presented to a tertiary headache center between January 2016 and December 2017, in addition to 1,934 adults with migraine but no visual snow. The three patients initially presented with headaches, and neurologic and MRI results were normal.

Two patients experienced black and white episodic visual snow and one experienced black and yellow visual snow. In one patient, visual snow occurred for less than 2 minutes before and during a migraine attack. The other two patients experienced visual snow during the entire migraine attack.

Based on these patients, the researchers proposed distinguishing episodic visual snow from the distinct disorder of visual snow syndrome, in which patients experience continuous visual snow and other visual symptoms.

In addition, the cases were notable because of the lack of aura in the patients, the researchers wrote.

“In clinical practice, a detailed history in patients reporting visual flickering is therefore necessary to differentiate aura from [episodic visual snow],” they added, because an aura diagnosis would affect patient guidance on contraception use or the timing of triptans.

Dr. Hodak had no financial conflicts to disclose. The study was supported by Deutsche Migräne-und Kopfschmerzgesellschaft, Eye on Vision Foundation, and Baasch-Medicus Foundation.

SOURCE: Hodak J et al. JAMA Neurol. 2019 Nov 25. doi: 10.1001/jamaneurol.2019.4050.

Episodic visual snow was tied to migraine attacks in a case series of three adults who denied any visual snow outside of the migraines, based on data collected at an outpatient headache center.

Visual snow, a condition in which patients experience visual distortion of tiny, flickering dots resembling analog television static, is often a comorbid condition in migraine patients with and without aura. However, “to our knowledge, this is the first report of patients with an episodic form of visual snow strictly occurring with migraine attacks,” wrote Julius Hodak, MD, of the University of Bern (Switzerland) and colleagues.

In a research letter published in JAMA Neurology, the investigators described 3 adults with histories of migraine but no aura who presented to a tertiary headache center between January 2016 and December 2017, in addition to 1,934 adults with migraine but no visual snow. The three patients initially presented with headaches, and neurologic and MRI results were normal.

Two patients experienced black and white episodic visual snow and one experienced black and yellow visual snow. In one patient, visual snow occurred for less than 2 minutes before and during a migraine attack. The other two patients experienced visual snow during the entire migraine attack.

Based on these patients, the researchers proposed distinguishing episodic visual snow from the distinct disorder of visual snow syndrome, in which patients experience continuous visual snow and other visual symptoms.

In addition, the cases were notable because of the lack of aura in the patients, the researchers wrote.

“In clinical practice, a detailed history in patients reporting visual flickering is therefore necessary to differentiate aura from [episodic visual snow],” they added, because an aura diagnosis would affect patient guidance on contraception use or the timing of triptans.

Dr. Hodak had no financial conflicts to disclose. The study was supported by Deutsche Migräne-und Kopfschmerzgesellschaft, Eye on Vision Foundation, and Baasch-Medicus Foundation.

SOURCE: Hodak J et al. JAMA Neurol. 2019 Nov 25. doi: 10.1001/jamaneurol.2019.4050.

Key clinical point: Patients with migraine were found to be at a higher risk for developing open angle glaucoma (OAG).

Major finding: Risk factors for OAG in patients with migraine were age, hyperlipidemia, and diabetes mellitus. There was 1.68-fold higher risk for OAG in migraine patients aged 49 years or less.

Study details: This was a retrospective matched-cohort study that included data from 17,283 patients with migraine, compared with 69,132 randomly selected patients. Migraine patients were followed for 10 years to determine if they would receive a diagnosis of OAG.

Disclosures: None.

Citation: Huang JY, et al. BMC Ophthalmol. 2019 Feb; doi: 10.1186/s12886-019-1062-9.

Key clinical point: Patients with migraine were found to be at a higher risk for developing open angle glaucoma (OAG).

Major finding: Risk factors for OAG in patients with migraine were age, hyperlipidemia, and diabetes mellitus. There was 1.68-fold higher risk for OAG in migraine patients aged 49 years or less.

Study details: This was a retrospective matched-cohort study that included data from 17,283 patients with migraine, compared with 69,132 randomly selected patients. Migraine patients were followed for 10 years to determine if they would receive a diagnosis of OAG.

Disclosures: None.

Citation: Huang JY, et al. BMC Ophthalmol. 2019 Feb; doi: 10.1186/s12886-019-1062-9.

Key clinical point: Patients with migraine were found to be at a higher risk for developing open angle glaucoma (OAG).

Major finding: Risk factors for OAG in patients with migraine were age, hyperlipidemia, and diabetes mellitus. There was 1.68-fold higher risk for OAG in migraine patients aged 49 years or less.

Study details: This was a retrospective matched-cohort study that included data from 17,283 patients with migraine, compared with 69,132 randomly selected patients. Migraine patients were followed for 10 years to determine if they would receive a diagnosis of OAG.

Disclosures: None.

Citation: Huang JY, et al. BMC Ophthalmol. 2019 Feb; doi: 10.1186/s12886-019-1062-9.

Key clinical point: Gender-related differences should be kept in mind when it comes to experiments and treatment approaches for migraine patients

Major finding: Female migraine patients were found to be more anxious, compared with male patients. They also had “more severe impairment in attentive processing of visual stimuli than their male counterparts,” noted the investigators.

Study details: Forty-six migraine patients without aura (23 females) and 46 age-matched healthy controls (23 females) were evaluated and analyzed using a three-stimulus oddball paradigm.

Disclosures: None.

Citation: Guo Y, et al. J Headache Pain. 2019;20(1):38. doi: 10.1186/s10194-019-0995-y.

Key clinical point: Gender-related differences should be kept in mind when it comes to experiments and treatment approaches for migraine patients

Major finding: Female migraine patients were found to be more anxious, compared with male patients. They also had “more severe impairment in attentive processing of visual stimuli than their male counterparts,” noted the investigators.

Study details: Forty-six migraine patients without aura (23 females) and 46 age-matched healthy controls (23 females) were evaluated and analyzed using a three-stimulus oddball paradigm.

Disclosures: None.

Citation: Guo Y, et al. J Headache Pain. 2019;20(1):38. doi: 10.1186/s10194-019-0995-y.

Key clinical point: Gender-related differences should be kept in mind when it comes to experiments and treatment approaches for migraine patients

Major finding: Female migraine patients were found to be more anxious, compared with male patients. They also had “more severe impairment in attentive processing of visual stimuli than their male counterparts,” noted the investigators.

Study details: Forty-six migraine patients without aura (23 females) and 46 age-matched healthy controls (23 females) were evaluated and analyzed using a three-stimulus oddball paradigm.

Disclosures: None.

Citation: Guo Y, et al. J Headache Pain. 2019;20(1):38. doi: 10.1186/s10194-019-0995-y.

Key clinical point: Migraine affects millions of patients in Europe. Yet, there aren’t enough specialists adhering to the national and international guidelines on migraines to treat those patients.

Major finding: Patients had seen general practitioners and neurologists for one year prior to seeing specialists. Fifty percent of those patients underwent unnecessary diagnostics and 34.2% had not been treated according to the recommended treatment guidelines.

Study details: Data was collected from 1,935 migraine patients between 2010 and 2018 visiting a headache clinic via standardized questionnaires regarding their prior history and treatment.

Disclosures: None.

Citation: Ziegeler C, et al. J Headache Pain. 2019;20(1):86. doi: 10.1186/s10194-019-1034-8.

Key clinical point: Migraine affects millions of patients in Europe. Yet, there aren’t enough specialists adhering to the national and international guidelines on migraines to treat those patients.

Major finding: Patients had seen general practitioners and neurologists for one year prior to seeing specialists. Fifty percent of those patients underwent unnecessary diagnostics and 34.2% had not been treated according to the recommended treatment guidelines.

Study details: Data was collected from 1,935 migraine patients between 2010 and 2018 visiting a headache clinic via standardized questionnaires regarding their prior history and treatment.

Disclosures: None.

Citation: Ziegeler C, et al. J Headache Pain. 2019;20(1):86. doi: 10.1186/s10194-019-1034-8.

Key clinical point: Migraine affects millions of patients in Europe. Yet, there aren’t enough specialists adhering to the national and international guidelines on migraines to treat those patients.

Major finding: Patients had seen general practitioners and neurologists for one year prior to seeing specialists. Fifty percent of those patients underwent unnecessary diagnostics and 34.2% had not been treated according to the recommended treatment guidelines.

Study details: Data was collected from 1,935 migraine patients between 2010 and 2018 visiting a headache clinic via standardized questionnaires regarding their prior history and treatment.

Disclosures: None.

Citation: Ziegeler C, et al. J Headache Pain. 2019;20(1):86. doi: 10.1186/s10194-019-1034-8.