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Abstract Details

Safety and Tolerability of Ubrogepant for the Acute Treatment of Migraine in Participants Taking Atogepant for the Preventive Treatment of Episodic Migraine: Results from the TANDEM Trial
Headache
S22 - Advances in Migraine and Therapeutics (1:48 PM-2:00 PM)
005
This study evaluated safety and tolerability of ubrogepant for acute treatment of migraine in participants taking atogepant for preventive treatment of episodic migraine (EM).
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved in U.S. for preventive treatment of migraine in adults. Ubrogepant is a CGRP receptor antagonist approved in U.S. for acute treatment of migraine with/without aura in adults. 

TANDEM, a phase 4, two-period, multicenter, open-label study conducted in U.S., enrolled adults with migraine, with/without aura, and <15 headache days/month. Period 1: participants treated with atogepant 60mg once daily (QD) for 12 weeks. Period 2: ubrogepant 100mg as needed (PRN) was added to atogepant for treatment of breakthrough migraine attacks (up to 8/month) for 12 weeks; optional second ubrogepant dose or participants’ own acute medication could be used to rescue unresolved headaches within 2-24 hours post-dose. Primary endpoint was safety and tolerability of atogepant and ubrogepant administered concomitantly.
Of 263 participants enrolled, 262 were treated in Period 1 (Safety Population 1) and 218 continued and were treated in Period 2 (Safety Population 2). Mean number of ubrogepant use days was 6.6 (SD, 5.03; min, max, 1, 24) over 12 weeks of Period 2 (n=188). In Safety Population 1, 49.6% of participants experienced a treatment-emergent adverse event (TEAE) versus 43.1% in Safety Population 2. Most common TEAEs (≥5%) in Safety Populations 1 and 2 were COVID-19 (8.4%, 3.2%), fatigue (6.5%, 1.4%), nausea (6.1%, 0.9%), decreased appetite (5.7%, 0.9%), and constipation (5.3%, 0.9%). 9.9% of participants discontinued any treatment due to TEAEs. There was 1 serious TEAE in each Period (Period 1, ureterolithiasis; Period 2, myelopathy); both considered unrelated to study treatment.
Use of atogepant 60mg QD for preventive treatment of EM and ubrogepant 100mg PRN for acute treatment of migraine over 12 weeks was safe and well tolerated.
Authors/Disclosures
Jessica Ailani, MD, FAAN (Medstar Georgetown Neurology)
PRESENTER 		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 $5,000-$9,999 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 $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $0-$499 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 $0-$499 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 Vectura. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Aeon. 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 Abbvie. 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 $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. Dr. Ailani has a non-compensated relationship as a Executive Board Member with American Headache Society that is relevant to AAN interests or activities.
Elimor Brand-Schieber, PhD (Axovant Gene Therapy) Dr. Brand-Schieber has received personal compensation for serving as an employee of AbbVie. Dr. Brand-Schieber has stock in AbbVie.
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 as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. 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.
Andrew M. Blumenfeld, MD, FAAN (The Los Angeles Headache Center) Dr. Blumenfeld has received personal compensation for serving as an employee of The Los Angeles Headache Center. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Allergan. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Best Doctors. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Guidepoint. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GLG. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theranica. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revance. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Abbvie. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Axon. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Blumenfeld has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck.
Molly He Molly He has nothing to disclose.
Jonathan H. Smith, MD (AbbVie) Dr. Smith has received personal compensation for serving as an employee of AbbVie. Dr. Smith has stock in 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.
Rosa De Abreu Ferreira Rosa De Abreu Ferreira has nothing to disclose.