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Abstract Details

Efficacy Is Maintained With Long-term Intermittent Use of Ubrogepant for the Acute Treatment of Migraine
Headache
P6 - Poster Session 6 (12:00 PM-1:00 PM)
7-012
Ubrogepant is a novel, oral CGRP receptor antagonist in development for the acute treatment of migraine. Long-term use for multiple attacks is anticipated.
To evaluate the efficacy of intermittent use of the oral calcitonin gene-related peptide (CGRP) receptor antagonist, ubrogepant, for acute treatment of migraine over 1 year.
Phase 3, multicenter, randomized, 52-week extension trial of adults with migraine randomized 1:1:1 to usual care, ubrogepant 50 mg, or ubrogepant 100 mg. Participants treated ≤8 migraine attacks (of any pain level) every 4 weeks for 1 year. Efficacy of ubrogepant treatment was assessed via pain freedom and pain relief at 2 hours, and use of rescue medication and optional second dose. We calculated the proportion of treated attacks achieving each efficacy endpoint for each participant, then averaged across equally weighted participants.
Of 1254 participants randomized, 808 made up the modified intent-to-treat (mITT) population. Mean participant age was 42 years and 21,454 migraine attacks were treated (31,968 ubrogepant doses). Pain freedom at 2 hours was achieved in an average of 23% (50 mg) and 25% (100 mg) of ubrogepant-treated attacks. Pain relief at 2 hours was achieved in 65% (50 mg) and 68% (100 mg) of ubrogepant-treated attacks. Efficacy was maintained over the 1-year period. An optional second dose of ubrogepant was taken for an average of 36% (50 mg) and 34% (100 mg) of ubrogepant-treated attacks. Rescue medication, other than ubrogepant, was used for an average of 13% (50 mg) and 12% (100 mg) of ubrogepant-treated attacks. Treatment-related adverse events were reported by 42/404 (10%) in the ubrogepant 50 mg group and 43/409 (10%) in the ubrogepant 100 mg group.
In this extension trial, efficacy comparable to the placebo-controlled, blinded phase 3 trials was achieved and maintained for 1 year. No safety concerns were identified.
Authors/Disclosures
Joel M. Trugman, MD, FAAN
PRESENTER
Dr. Trugman has received personal compensation for serving as an employee of AbbVie. Dr. Trugman has stock in AbbVie.
Jessica Ailani, MD, FAAN (Medstar Georgetown Neurology) Dr. Ailani has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Allergan/Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Amgen. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GlaxoSmithKline. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Gore. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurolief. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Scilex. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dr. Reddy. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eneura. Dr. Ailani has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Linpharma. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Pain and Headache Report. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Medscape. The institution of Dr. Ailani has received research support from Satsuma. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Medical Advisor with SELF.
Susan Hutchinson Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alder Pharmaceutical. Susan Hutchinson has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Allergan Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen Pharmaceutical. Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Currax Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for electroCore. Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $0-$499 for serving as a Consultant for Lundbeck Pharmaceutical. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Upsher Smith. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/AbbVie. Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven . Susan Hutchinson has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Lilly Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck . Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva . Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Headache Cooperative of the Pacific . Susan Hutchinson has received publishing royalties from a publication relating to health care.
Kerry L. Knievel, DO (Barrow Neurological Institute) Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for amgen . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven . An immediate family member of Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck . Dr. Knievel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Upsher Smith . Dr. Knievel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica . Dr. Knievel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Knievel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven . Dr. Knievel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Headache Cooperative of the Pacific . Dr. Knievel has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Pfizer. Dr. Knievel has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Sanders and Parks. The institution of Dr. Knievel has received research support from Abbvie . The institution of Dr. Knievel has received research support from Alder.
No disclosure on file
Sung Y. Yu Sung Y. Yu has received personal compensation for serving as an employee of Abbvie. Sung Y. Yu has received stock or an ownership interest from Abbvie.
Michelle Finnegan Michelle Finnegan has received personal compensation for serving as an employee of AbbVie.
No disclosure on file
No disclosure on file
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine) Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has stock in Biohaven. Dr. Lipton has stock in Manistee. Dr. Lipton has stock in Axon. Dr. Lipton has stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.