M24-305 Atogepant for the Acute Treatment of Migraine
Research type
Research Study
Full title
Randomized, Double-Blind, Placebo-Controlled, Multiple-Attack Study with an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE)
IRAS ID
1008359
Contact name
Alok Tyagi
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2023-506029-12
Research summary
A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and
well-tolerated in treating migraine attacks quickly.
Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor
the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the
world.
All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24).REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0224
Date of REC Opinion
10 Jan 2024
REC opinion
Further Information Favourable Opinion