New Investigational Treatments and Findings on Migraine Highlight Therapeutic Advancements

New Investigational Treatments and Findings on Migraine Highlight Therapeutic Advancements

New Investigational Treatments and Findings on Migraine at the 2018 American Headache Society Annual Scientific Meeting Highlight Therapeutic Advancements

[SAN FRANCISCO, CA, June 27, 2018] – The American Headache Society (AHS) announced results from late-breaking studies that will be presented at the 60th Annual Scientific Meeting, June 28 – July 1, 2018 in San Francisco, California. Among them are findings on investigational treatments for cluster headache and migraine including those targeting calcitonin gene-related peptide (CGRP) mechanisms and neuromodulation. Work on medication overuse headache in association with adverse childhood experiences; and distinguishing brain nerve-fiber profiles in patients with migraine and post-traumatic headache will be presented. The AHS Annual Scientific Meeting brings together more than 1,000 migraine and headache specialists from around the world.

“These studies bring us closer to realizing the potential of novel therapies for those in substantial need,” said Peter Goadsby, MD, PhD, FAHS, AHS Scientific Program Committee Chair, Professor of Neurology at King’s College, London and University of California, San Francisco and Director of NIHR-Welcome Trust Clinical Research Facility, King’s College Hospital, London. “The American Headache Society has been at the forefront of improving the understanding of migraine and other types of headache, and we thank the patients who participated in the studies, as well as the physicians that contributed to these important studies.”

Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist Treatment of Migraine Offers Significant and Meaningful Results

• “Ubrogepant for the Acute Treatment of Migraine: Efficacy, Safety, Tolerability, and Functional Impact Outcomes from a Single Attack Phase III Study, ACHIEVE I”
  This large, multicenter, randomized, double-blind, single-attack study evaluated the efficacy, safety and tolerability of ubrogepant 50 mg, ubrogepant 100 mg vs placebo for the treatment of a single migraine attack. Migraine involves a neuropeptide called calcitonin gene-related peptide (CGRP). Ubrogepant is a novel, oral CGRP receptor antagonist in development for the acute treatment of migraine. Results of this study, which included 1672 patients, showed that, two hours after the initial study treatment dose, the percentage of ubrogepant-treated patients achieving pain freedom was significantly higher than placebo-treated patients, and the difference continued after the two hours. Those treated with ubrogepant also achieved a significantly greater absence of migraine-associated symptoms at two hours, and a higher proportion experienced no disability and the ability to function normally. Throughout the study, ubrogepant was well-tolerated with no identified safety concerns.
• “Efficacy, Safety, and Tolerability of Rimegepant 75 mg, an Oral CGRP Receptor Antagonist, for the Acute Treatment of Migraine: Results from a Double-Blind, Randomized, Placebo-Controlled Trial, Study 302”
  This large, multicenter, randomized, double-blind trial evaluated the efficacy, safety, and tolerability of CGRP receptor antagonist, rimegepant (75 mg oral tablet) compared with placebo in the acute treatment of migraine. Outcomes of the study, which included 1186 adults, showed rimegepant-treated patients had higher pain freedom at two hours post-initial dose and were more likely to be free of most bothersome symptom. Also, a greater proportion of rimegepant-treated patients achieved normal functional ability at two hours after the initial dose.
• “Study CGAL: A Phase 3 Placebo-Controlled Study of Galcanezumab in Patients with Episodic Cluster Headache: Results from the 8-Week Double-Blind Treatment Phase”
  This double-blind, placebo-controlled Phase 3 study evaluated galcanezumab (LY2951742), a monoclonal antibody that targets CGRP, as a treatment to prevent episodic cluster headache. Study results showed that galcanezumab 300 mg, compared to placebo, produced significant improvements and reductions of cluster headache frequency across weeks 1 to 3, with a significantly greater percentage of patients achieving a 50% reduction in frequency at week 3. The safety profile of galcanezumab in these patients was similar to that seen previously in trials that evaluated galcanezumab in patients with episodic and chronic migraine.

Study Finds Varying Profiles in Patients with Migraine versus Post-Traumatic Headache

• “Differences in fiber tract profiles between patients with migraine and those with persistent post-traumatic headache”
  This study evaluated 131 subjects, including 49 patients with persistent post-traumatic headache (PPTH), 41 patients with migraine and 41 healthy controls, to better understand the similarities and differences in neuropathological underpinnings of PPTH and migraine. The study compared fiber tract profiles (an assessment of the architecture of certain nerve fibers in the brain) of patients with migraine and those with PPTH, and of both those cohorts to a group of healthy controls. Results suggested potential differences in the neuropathological mechanisms essential to migraine and PPTH, specifically with migraine having a positive association between headache frequency and a measure called mean diffusivity in a certain area of the brain. These findings suggest headache burden may relate to changes in the fiber tract profiles and that point-by-point measurements could potentially reveal specific changes in migraine and PPTH patients that otherwise go undetected.

Study Examines Links Between Medication Overuse Headache and Adverse Childhood Experience

• “Adverse childhood experience and medication overuse headache; frequency and effects on response to treatment”
  A retrospective chart review was conducted in 72 patients to examine the frequency of adverse childhood experience (ACE) associated with medication overuse headache (MOH), in particular MOH related to narcotic use. Opioids and barbiturates carry the highest risk for MOH and ACE has been identified as a risk factor for development of chronic headache. Results showed trends of more opioid use among ACE patients. More than half of study participants reporting ACE were more likely to have a psychiatric diagnosis and overuse opioids. Those patients overusing narcotics had a significantly lower rate of MOH elimination.

Study Finds Sphenopalatine Ganglion Stimulation is Effective in Chronic Cluster Headache

• “Sphenopalatine Ganglion Stimulation is effective for chronic cluster headache – A sham-controlled study”
  This randomized study evaluated the role of sphenopalatine ganglion (SPG) stimulation in patients with chronic cluster headache. In this study, investigators implanted a neuromodulator in patients who were then assigned to treatment with a handheld device that either stimulated the SPG, a group of nerves linked to the main nerve involved with headache, or delivered electrical stimulation only to the skin in the same area (sham control group). The study showed that, compared to the sham group, the SPG group achieved significant pain relief and pain freedom at 15 minutes after initiation of the electrical stimulation therapy. Additionally, the SPG treatment reduced headache attack frequency in patients with ipsilateral cluster attacks. The SPG treatment was well tolerated, with four related serious adverse events involving the device and/or procedure, all of which completely resolved.

About Migraine
Migraine is a major disabling neurological disease that affects more than over 37 million men, women and children in the United States. The disease impacts one in four households, one in five women, one in 16 men and one in 11 children in the United States. Globally, migraine is the sixth highest cause of years of life lost due to disability. Individuals who experience migraine have symptoms that include nausea, sensitivity to light and/or odors, skin sensitivity, fatigue, mood change, dizziness, difficulty concentrating, neck pain and changes in vision, including seeing spots, stars, lines, flashing lights and zigzag lines. The risk of other serious diseases is significantly higher in those with migraine, including stroke, epilepsy, depression, anxiety and chronic pain. Despite this, only one of every three people talk with a doctor about their migraine attacks and of those, only half get the right diagnosis. There is also a massive shortage of specialists focusing on migraine, with one specialist for every 65,000 individuals living with migraine, which worsens the problem.

About the American Headache Society
The American Headache Society (AHS) is a professional society of health care providers dedicated to the study and treatment of headache and face pain. The Society’s objectives are to promote the exchange of information and ideas concerning the causes and treatments of headache and related painful disorders. Educating physicians, health professionals and the public and encouraging scientific research are the primary functions of this organization. AHS activities include an annual scientific meeting, a comprehensive headache symposium, regional symposia for neurologists and family practice physicians, and publication of the journal Headache. More information can be found at www.americanheadachesociety.org. In 2010, AHS founded the American Migraine Foundation (AMF) to provide access to information and resources for individuals living with migraine, as well as their loved ones. AMF is a non-profit organization dedicated to the advancement of research and awareness surrounding migraine. Patients can learn more, find help and get connected by visiting www.americanmigrainefoundation.org.

CONTACT: Alyssa Bleiberg, Alyssa.Bleiberg@syneoshealth.com, +1 212 845 5628 and +1 973 432 7289