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Abstract Details

Atogepant for the Preventive Treatment of Migraine Among Participants With Episodic Migraine With Prior Treatment Failure: Results From the ELEVATE Trial
Headache
ES2 - Emerging Science 2 (6:06 PM-6:12 PM)
007

Atogepant, an oral calcitonin gene-related peptide receptor antagonist, is approved for the preventive treatment of EM in adults in the United States.

To evaluate the efficacy, safety, and tolerability of atogepant 60 mg once daily (QD) for the preventive treatment of episodic migraine (EM) in participants who have previously failed 2 to 4 classes of oral preventive medications.

ELEVATE was a randomized, double-blind, placebo-controlled trial conducted in Europe and North America. Adults (18-80 years) who previously failed 2-4 classes of conventional oral medications for migraine prevention and reported 4-14 monthly migraine days (MMDs) during the 28-day screening period were randomized to treatment with atogepant 60 mg QD or placebo. The primary endpoint was the change from baseline in mean MMDs across 12 weeks. Secondary endpoints included achievement of ≥50% reduction in MMDs, change from baseline in mean monthly headache days, and change from baseline in acute medication use days across 12 weeks.

A total of 309 participants were included in the efficacy analysis population (placebo: n=155; atogepant 60 mg QD: n=154). Of these participants, 56.0% failed 2 classes of oral migraine preventive medications and 44.0% failed ≥3 classes. A significantly greater decrease in MMDs (mean [standard error]) across the 12-week treatment period was observed with atogepant 60 mg QD (−4.20 [0.39]) vs placebo (−1.85 [0.39]; P<0.0001). All secondary endpoints demonstrated statistically significant improvement with atogepant vs placebo across the 12-week treatment period. The most commonly (≥5%) reported treatment-emergent adverse events (atogepant vs placebo, respectively) included constipation (10.3% vs 2.5%), COVID-19 (8.3% vs 9.6%), nausea (7.1% vs 3.2%), and nasopharyngitis (5.1% vs 7.6%).

Atogepant 60 mg QD was efficacious, safe, and well-tolerated for the preventive treatment of EM in participants who previously failed 2-4 classes of oral preventive migraine medications.

Authors/Disclosures
Cristina Tassorelli
PRESENTER
Cristina Tassorelli 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. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Dompè. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pfizer. The institution of Cristina Tassorelli has received research support from Abbvie.
Patricia Pozo-Rosich, MD, PhD Dr. Pozo-Rosich has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pozo-Rosich has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Pozo-Rosich has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Pozo-Rosich has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly Foundation Spain. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sociedad Española Neurologia.
Krisztian Nagy, MD (AbbVie) Dr. Nagy has received personal compensation for serving as an employee of AbbVie. Dr. Nagy has stock in AbbVie.
Michel Lanteri-Minet, MD (CHU De Nice) Dr. Lanteri-Minet has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Lanteri-Minet has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eli Lilly. The institution of Dr. Lanteri-Minet has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Lanteri-Minet has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. The institution of Dr. Lanteri-Minet has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Medtronic. Dr. Lanteri-Minet has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TEVA. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UPSA. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IPSEN. Dr. Lanteri-Minet has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. The institution of Dr. Lanteri-Minet has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Pfizer. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Savia BioElectronics. Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ReckittBenckiser. The institution of Dr. Lanteri-Minet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zambon. Dr. Lanteri-Minet has received publishing royalties from a publication relating to health care.
Sara E. Sacco, MD (Carolinas Headache Clinic, PA) The institution of Dr. Sacco has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie/Allergan. The institution of Dr. Sacco has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. The institution of Dr. Sacco has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. The institution of Dr. Sacco has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Impel Neuropharma. The institution of Dr. Sacco has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TEVA. The institution of Dr. Sacco has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI (Now Collegium). The institution of Dr. Sacco has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/Abbvie. The institution of Dr. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. The institution of Dr. Sacco has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. The institution of Dr. Sacco has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eli Lilly. The institution of Dr. Sacco has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Impel NeuroPharma. Dr. Sacco has received personal compensation in the range of $10,000-$49,999 for serving as a Key Opinion Leader with Teva.
Tomas Nezadal, PhD (Military University Hospital) Dr. Nezadal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Nezadal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Nezadal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Nezadal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Nezadal has received personal compensation in the range of $0-$499 for serving as a Consultant for Abbvie. Dr. Nezadal has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for endowment fund Hedalga.
Michelle Finnegan Michelle Finnegan has received personal compensation for serving as an employee of AbbVie.
Hua Guo, PhD (AbbVie) Hua Guo has received personal compensation for serving as an employee of AbbVie. Hua Guo has received stock or an ownership interest from AbbVie.
Rosa Liliana De Abreu Ferreira, MD (Abbvie) Dr. De Abreu Ferreira has received personal compensation for serving as an employee of AbbVie. Dr. De Abreu Ferreira 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.