Â鶹´«Ã½Ó³»­

Â鶹´«Ã½Ó³»­

Explore the latest content from across our publications
Join The Â鶹´«Ã½Ó³»­

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Efficacy and Safety of Ubrogepant in Participants Taking Concomitant Preventive Medication
Headache
P7 - Poster Session 7 (5:30 PM-6:30 PM)
7-008
To evaluate the potential impact of concomitant preventive medication use on the efficacy and safety of ubrogepant for the acute treatment of migraine.
Ubrogepant is a novel calcitonin gene–related peptide (CGRP) receptor antagonist in development for the acute treatment of migraine. People with migraine are commonly treated with both acute and preventive medications.
ACHIEVE I and ACHIEVE II were multicenter, double-blind, single-attack, phase 3 trials in which adults with a history of migraine were randomized to placebo or ubrogepant (50 mg or 100 mg, ACHIEVE I; 25 mg or 50 mg, ACHIEVE II). Data from ubrogepant 50 mg and placebo were pooled for this analysis. Co-primary endpoints (pain freedom and MBS freedom) and pain relief at 2 hours postdose were evaluated in the subgroups with and without concomitant preventive medication use. After completion of the ACHIEVE trials, participants could enroll in an open-label, 52-week extension trial and were randomized in a blinded fashion to ubrogepant 50 mg or 100 mg. Safety and tolerability were assessed.
The analysis included 2246 participants from ACHIEVE trials; 417 (18.6%) reported use of preventive treatments. In the long-term extension trial, 813 participants were included in the safety population; 143 (17.6%) reported preventive use. No significant negative impact of concomitant medication use was observed on pain freedom, MBS freedom, or pain relief at 2 hours (P>0.05). A numerically greater therapeutic gain was found for those who reported concomitant preventive medication use compared with those who did not. In the long-term extension study, TEAEs and treatment-related TEAEs were reported at similar rates between participants who did and did not report concomitant preventive medication use.
Concomitant preventive medication use did not impact the efficacy of ubrogepant for the acute treatment of migraine and was not associated with additional safety concerns.
Authors/Disclosures
Andrew M. Blumenfeld, MD, FÂ鶹´«Ã½Ó³»­ (Cedars Sinai)
PRESENTER 		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/Abbvie. 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 $50,000-$99,999 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 $50,000-$99,999 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 $100,000-$499,999 for serving as a Consultant for Cedar Sinai. 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/Abbvie. 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 $10,000-$49,999 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/Abbvie. 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 $50,000-$99,999 for serving on a Speakers Bureau for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AXSOME.
Kerry L. Knievel, DO, FÂ鶹´«Ã½Ó³»­ (Barrow Neurological Institute) Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Knievel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. Dr. Knievel 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. Knievel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven . Dr. Knievel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck . Dr. Knievel 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 . The institution of Dr. Knievel has received research support from Abbvie .
Aubrey Adams, PhD Dr. Manack Adams has received personal compensation for serving as an employee of Abbvie. Dr. Manack Adams has stock in Abbvie.
No disclosure on file
No disclosure on file
No disclosure on file
David W. Dodick, MD, FÂ鶹´«Ã½Ó³»­ (Atria Institute) Dr. Dodick has received personal compensation for serving as an employee of Mayo Clinic. Dr. Dodick has received personal compensation for serving as an employee of Atria Health. Dr. Dodick has received personal compensation for serving as an employee of Thomas Jefferson University . Dr. Dodick has received personal compensation for serving as an employee of Norwegian University of Science and Technology. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Dodick has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Allergan. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biopharm Communications. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Inside Practice Australia. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clinical Â鶹´«Ã½Ó³»­ Alliance. Dr. Dodick has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Headache Cooperative of the Pacific . Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medica Communications. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MJ Healthcare. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nocira. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Praxis. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance . Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Synapse Medical Communications. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vector Psychometrics. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as a Consultant for Ayya Biosciences. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as a Consultant for Theranica. Dr. Dodick has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Atria. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for WebMD. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Thomas Jefferson University. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medforce. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Precision HEOR. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Canadian Headache Society. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Headache Cooperative of New England. Dr. Dodick has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen Japan. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for KingDevick Technologies. Dr. Dodick has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Precon Health. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Ontologics. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Matterhorn. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Axon Therapeutics. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Cephalgia Group. Dr. Dodick has stock in Healint. Dr. Dodick has stock in Theranica. Dr. Dodick has stock in Aural Analytics . Dr. Dodick has stock in Epien. Dr. Dodick has stock in Matterhorn. Dr. Dodick has stock in Ontologics. Dr. Dodick has stock in Precon Health. Dr. Dodick has stock in King Devick Technologies. Dr. Dodick has stock in Nocira. Dr. Dodick has stock in Exsano. Dr. Dodick has stock in Palion. Dr. Dodick has stock in AYYA Biosciences. Dr. Dodick has stock in Perfood. Dr. Dodick has stock in Cephalgia Group. Dr. Dodick has stock in Atria Health. Dr. Dodick has stock in Man and Science. Dr. Dodick has stock in Eigenlyfe. An immediate family member of Dr. Dodick has stock in ScotiaLyfe. Dr. Dodick has stock in Axon Therapeutics. The institution of Dr. Dodick has received research support from Department of Defense. The institution of Dr. Dodick has received research support from Patient Centered Outcomes Research Institute. The institution of Dr. Dodick has received research support from Henry Jackson Foundation. Dr. Dodick has received intellectual property interests from a discovery or technology relating to health care. Dr. Dodick has received intellectual property interests from a discovery or technology relating to health care. Dr. Dodick has received intellectual property interests from a discovery or technology relating to health care. Dr. Dodick has received publishing royalties from a publication relating to health care. Dr. Dodick has received publishing royalties from a publication relating to health care. Dr. Dodick has received publishing royalties from a publication relating to health care. Dr. Dodick has a non-compensated relationship as a Chair with American Brain Foundation that is relevant to Â鶹´«Ã½Ó³»­ interests or activities. Dr. Dodick has a non-compensated relationship as a Committee member/Course Director with Â鶹´«Ã½Ó³»­ that is relevant to Â鶹´«Ã½Ó³»­ interests or activities. Dr. Dodick has a non-compensated relationship as a Chair/Immediate Past Chair with American Migraine Foundation that is relevant to Â鶹´«Ã½Ó³»­ interests or activities. Dr. Dodick has a non-compensated relationship as a Chair Global Patient Advocacy Coalition with International Headache Society that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.