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Abstract Details

Eptinezumab Demonstrates Early Relief from Episodic and Chronic Migraine: Consistency of Effect Across 4 Clinical Trials
Headache
S17 - Headache: Clinical Trials I (1:33 PM-1:44 PM)
004
An unmet migraine preventive treatment need exists for treatments that have a rapid onset of effect. Eptinezumab, a humanized anti-CGRP monoclonal antibody with 100% bioavailability following intravenous administration, demonstrated significant migraine reduction and acceptable safety in 4 migraine prevention trials.
To demonstrate the consistency in migraine reduction from Day 1 through Month 1 in patients with episodic migraine (EM) or chronic migraine (CM) treated with eptinezumab. 

Four double-blind, placebo-controlled, randomized trials evaluated eptinezumab for the preventive treatment of migraine: NCT01772524 (EM, phase 2), NCT02559895 (EM, phase 3, PROMISE-1), NCT02275117 (CM, phase 2b), NCT02974153 (CM, phase 3, PROMISE-2). The percentage of patients experiencing a migraine (assessed using eDiary entries) was evaluated on Day 1, then as an averaged daily occurrence weekly through Week (Wk) 4; baseline was the average over the 28-day screening period.

In the EM trials, approximately 31% of patients experienced a migraine on any given day during the screening period. PROMISE-1: rates on Day 1 were 22.5% (placebo), 13.9% (300mg), 14.8% (100mg); 20.5%, 14.4%, 15.9% during Wk1; 20.5%, 15.8%, 17.1% during Wk4. NCT01772524: percentage of patients with a migraine on Day 1 was 13.7% (placebo) and 4.8% (1000mg); 18.4% and 9.8% during Wk1; 17.6% and 10.0% during Wk4.

 

In the CM trials, approximately 58%-59% of patients experienced a migraine on any given day during the screening period. PROMISE-2: rates on Day 1 were 42.3% (placebo), 27.8% (300mg), 28.6% (100mg); 40.6%, 28.8%, 31.3% during Wk1; 36.0%, 28.8%, 31.8% during Wk4. NCT02275117: percentage of patients with a migraine on Day 1 was 48.7% (placebo), 26.5% (300mg), 29.3% (100mg); 41.7%, 31.9%, 31.8% during Wk1; 41.0%, 30.1%, 30.2% during Wk4.

Across 4 migraine prevention trials, eptinezumab consistently demonstrated rapid onset of migraine preventive benefit beginning Day 1 after treatment and maintained weekly through Month 1.

Authors/Disclosures
David W. Dodick, MD, FAAN (Atria Institute)
PRESENTER
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 好色先生 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 AAN interests or activities. Dr. Dodick has a non-compensated relationship as a Committee member/Course Director with 好色先生 that is relevant to AAN interests or activities. Dr. Dodick has a non-compensated relationship as a Chair/Immediate Past Chair with American Migraine Foundation that is relevant to AAN 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 AAN interests or activities.
No disclosure on file
Roger Cady, MD (RK Consulting, LLC) Dr. Cady has received personal compensation for serving as an employee of Lundbeck. Dr. Cady has stock in Alder Biopharmaceutical.
Barbara Schaeffler No disclosure on file
Jeff Smith (Alder Biopharmaceuticals) No disclosure on file
David M. Biondi, DO, FAAN Dr. Biondi has received personal compensation for serving as an employee of Cohen Veterans Bioscience, Inc. Dr. Biondi has received personal compensation for serving as an employee of Alder Biopharmaceuticals, Inc. Dr. Biondi has received stock or an ownership interest from Johnson & Johnson . The institution of Dr. Biondi has received research support from US Department of Defense .
No disclosure on file