Abstract Details

Title Evaluation of the Long-Term Safety and Tolerability of Oral Atogepant 60 Mg Once Daily for Preventive Treatment of Migraine: A Phase 3, 40-Week, Multicenter Extension to the Advance Trial

Topic Headache

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-001

Background Atogepant is an oral small molecule calcitonin gene-related peptide (CGRP) receptor antagonist under investigation as a preventive treatment of migraine. Daily atogepant administration was shown to be safe and effective at episodic migraine prevention via 2 placebo-controlled, double-blinded, randomized clinical trials (Phase 2b/3, NCT02848326; and, Phase 3 ADVANCE, NCT03777059).

Objective To evaluate the long-term safety and tolerability of atogepant over 40 weeks in participants who completed the pivotal 12-week ADVANCE trial.

Design/Methods Participants in this open-label extension trial (NCT03939312) were rolled over from the lead-in ADVANCE trial and were treated with atogepant 60 mg once daily for 40-weeks, with a 4-week safety follow-up period. Only safety data were collected.

Results 685 participants took at least one dose of study drug, 74.6% completed the 40-week treatment period; mean age of 41.8 years, 88.2% female, 84.4% white, and mean BMI of 30.58 kg/m2. Mean (SD) treatment duration was 233.6 (89.32) days. Overall, 62.5% of participants experienced a treatment-emergent adverse event (TEAE), with 8.8% considered treatment-related by the investigator; serious adverse events (SAEs) occurred in 3.4% of participants, none were treatment-related. The most frequent AE leading to discontinuation was nausea (0.4%, n=3), and the most frequent TEAEs observed included upper respiratory tract infection (5.5%, n=38) and urinary tract infection (5.3%, n=36). No deaths and no hepatic safety issues were observed.

Conclusions These safety results are consistent with the known safety profile of atogepant from previous trials and support the long-term safety and tolerability of once daily dosing of atogepant 60 mg.

Authors/Disclosures
Brad C. Klein, MD, MBA, FAAN (Abington Neurological Associates, Ltd.) PRESENTER	Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly and Company. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AbbVie. Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eli Lilly and Company. Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biohaven. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Impel. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biodelivery Science. The institution of Dr. Klein has received research support from AbbVie. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving as a Shareholder with AppsbyDocs, LLC. Dr. Klein has a non-compensated relationship as a Chair, Practice Management Committee with American Headache Society that is relevant to AAN interests or activities.
	No disclosure on file
	No disclosure on file
Peter J. McAllister, MD, FAAN (New England Inst for Neurology and Headache)	Dr. McAllister has received personal compensation for serving as an employee of Revance. Dr. McAllister has received personal compensation for serving as an employee of AbbVie. Dr. McAllister has received personal compensation for serving as an employee of Merz. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aeon. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for lilly. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for teva. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for abbvie. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for biohaven. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for lundbeck.
Laszlo Mechtler, MD, FASN, FAAN (Dent Neurologic Institute)	Dr. Mechtler has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Jushi Inc. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Mechtler has received stock or an ownership interest from Jushi Co.. The institution of Dr. Mechtler has received research support from The Harry Dent Family Foundation, Inc. The institution of Dr. Mechtler has received research support from Amgen/Novartis. The institution of Dr. Mechtler has received research support from Alder/ Lundbeck. The institution of Dr. Mechtler has received research support from Abbvie/Allergan. The institution of Dr. Mechtler has received research support from Miles for Migraine. The institution of Dr. Mechtler has received research support from American Migraine Foundation. The institution of Dr. Mechtler has received research support from Charlotte's Web.
Jennifer W. McVige, MD (Dent Neurological Institute)	Dr. McVige has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theranica. Dr. McVige 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. Dr. McVige has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/AbbVie. Dr. McVige has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. McVige has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. McVige has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eli Lilly. Dr. McVige has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. McVige has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurelis. The institution of Dr. McVige has received research support from Amgen. The institution of Dr. McVige has received research support from Eli Lily. The institution of Dr. McVige has received research support from Biohaven. The institution of Dr. McVige has received research support from Lundbeck. The institution of Dr. McVige has received research support from Dent Family Foundation. Dr. McVige has a non-compensated relationship as a Neurology Board with UCNS that is relevant to AAN interests or activities. Dr. McVige has a non-compensated relationship as a Board Exam Board Member with ABPN that is relevant to AAN interests or activities.
Merle Diamond	No disclosure on file
Michael J. Marmura, MD, FAAN (Thomas Jefferson University)	Dr. Marmura has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Marmura has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome. Dr. Marmura 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. Marmura has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Marmura has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Marmura has stock in Curelator. The institution of Dr. Marmura has received research support from Teva. The institution of Dr. Marmura has received research support from AbbVie. Dr. Marmura has received publishing royalties from a publication relating to health care. Dr. Marmura has received publishing royalties from a publication relating to health care. Dr. Marmura has received publishing royalties from a publication relating to health care.
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.
Michelle Finnegan	Michelle Finnegan has received personal compensation for serving as an employee of 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.