Abstract Details

Title Ubrogepant Was Safe and Well Tolerated in the Acute Treatment of Perimenstrual Migraine

Topic Headache

Presentation(s) S5 - Headache 1 (4:32 PM-4:40 PM)

Poster/Presentation
Number 004

Objective To determine the efficacy and safety of ubrogepant in the acute treatment of perimenstrual migraine (pmM) attacks.

Background Ubrogepant is an oral calcitonin gene–related peptide receptor antagonist approved for the acute treatment of migraine in adults. More than 50% of women report an association between migraine attacks and monthly menstruation.

Design/Methods Phase 3, multicenter, randomized, open-label, 52-week extension trial of adults with migraine randomized 1:1:1 to usual care, ubrogepant 50mg, or ubrogepant 100mg. Participants treated ≤8 migraine attacks every 4 weeks for 1 year. A migraine headache attack was considered perimenstrual (pmM) if it started on or between 2 days before and 3 days after the start of menstrual bleeding. Menstruation included withdrawal bleeding from exogenous hormones. Ubrogepant efficacy was assessed via pain freedom and pain relief at 2 hours. Safety and tolerability were also assessed.

Results The trial included 808 ubrogepant participants in the modified intent-to-treat population who treated 21,419 migraine attacks with ubrogepant. 354 (43.8%) were menstruating women of whom 278 (78.5%) treated at least 1 pmM. 8,620 (40.2%) pmMs were treated in total. In the 50mg dose group, pain freedom at 2 hours was achieved in a significantly greater percentage of ubrogepant-treated pmMs (28.7%) compared with non-pmMs (22.3%, P=0.046). In the 100mg dose group, pain freedom at 2 hours was achieved in 29.7% of ubrogepant-treated pmMs compared with 24.8% of non-pmMs (P=0.406). Pain relief at 2 hours was achieved in 64.8% of pmMs vs 64.9% of non-pmMs in the 50mg dose group (P=0.396) and 67.1% vs 67.8% in the 100mg dose group (P=0.253). Treatment-related adverse events were reported by 18/137 (12.8%) and 12/141 (8.8%) in the ubrogepant 50mg and 100mg subgroups of participants who experienced a pmM, respectively.

Conclusions In this randomized 52-week extension trial, efficacy of ubrogepant for the treatment of pmMs was comparable to that observed for non-pmMs.

Authors/Disclosures
Jelena M. Pavlovic, MD, PhD (Albert Einstein College of Medicine) PRESENTER	Dr. Pavlovic has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven.
Jessica Ailani, MD, FAAN (Medstar Georgetown Neurology)	Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 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 $10,000-$49,999 for serving as a Consultant for Pfizer. 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 $10,000-$49,999 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 Aspya. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. 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 Kallyope. 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 Self Magazine. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. The institution of Dr. Ailani has received research support from Lundbeck. The institution of Dr. Ailani has received research support from Merz. The institution of Dr. Ailani has received research support from Pfizer. Dr. Ailani has received research support from Mi-Helper. The institution of Dr. Ailani has received research support from ShiraTronic. Dr. Ailani has a non-compensated relationship as a Executive Board Member with American Headache Society that is relevant to AAN interests or activities.
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.
	No disclosure on file
Brett Dabruzzo, PharmD (AbbVie Medical Affairs)	Dr. Dabruzzo has received personal compensation for serving as an employee of AbbVie. Dr. Dabruzzo has stock in AbbVie.
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.
Joel M. Trugman, MD, FAAN	Dr. Trugman has received personal compensation for serving as an employee of AbbVie. Dr. Trugman has stock in AbbVie.
	No disclosure on file

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