好色先生

好色先生

Explore the latest content from across our publications
Join The AAN

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

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
Headache
P3 - Poster Session 3 (5:30 PM-6:30 PM)
15-001
To evaluate the long-term safety and tolerability of atogepant over 40 weeks in participants who completed the pivotal 12-week ADVANCE trial.
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).
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.
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.
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 $5,000-$9,999 for serving as a Consultant for Lundbeck. 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 $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 Axsome. 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 in the range of $10,000-$49,999 for serving as a Consultant for pfizer. 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 $5,000-$9,999 for serving on a Speakers Bureau for abbvie. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for lundbeck.
Laszlo Mechtler, MD, FEAN, FASN, FAHS, FAAN (Dent Neurologic Institute) Dr. Mechtler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel Pharma. Dr. Mechtler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Mechtler has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Mechtler 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 Genomate Health. 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 Alpheus medical. The institution of Dr. Mechtler has received research support from Shiratronics. The institution of Dr. Mechtler has received research support from Abbvie Inc. The institution of Dr. Mechtler has received research support from Amgen. The institution of Dr. Mechtler has received research support from Eli Lilly Company. The institution of Dr. Mechtler has received research support from H. Lundbeck HS. The institution of Dr. Mechtler has received research support from Pfizer. Dr. Mechtler has received personal compensation in the range of $100,000-$499,999 for serving as a Ownership interest with Neurology Practce Consortium GPO. Dr. Mechtler has a non-compensated relationship as a Board member with International Headache Society that is relevant to AAN interests or activities.
Jennifer W. McVige, MD, FAAN (Dent Neurological Institute) Dr. McVige has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. McVige has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie. Dr. McVige has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for UCB. 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/Pfizer. The institution of Dr. McVige has received research support from Lundbeck. The institution of Dr. McVige has received research support from Dent Family Foundation. The institution of Dr. McVige has received research support from Abbvie. The institution of Dr. McVige has received research support from Teva. The institution of Dr. McVige has received research support from Theranica. 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 Merle Diamond has received personal compensation for serving as an employee of Diamond Headache Clinic. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal Pharmaceuticals. Merle Diamond has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for AbbVie . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel Neuropharma. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva Pharmaceuticals. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome Therapeutics. Merle Diamond 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 . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome Therapeutics. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Impel Neuropharma. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amneal Pharmaceuticals'. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva Pharmaceuticals Industries Ltd. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Axsome Pharma. Merle Diamond has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie . Merle Diamond has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Impel Neuropharma. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva Pharmautical Industries Ltd. Merle Diamond has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Lundbeck . Merle Diamond has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for National Headache Foundation .
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 AbbVie. The institution of Dr. Marmura has received research support from Teva. The institution of Dr. Marmura has received research support from AbbVie. The institution of Dr. Marmura has received research support from Axsome. The institution of Dr. Marmura has received research support from Pfizer. 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) Dr. Guo has received personal compensation for serving as an employee of AbbVie. Dr. Guo has or had stock in 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.