Atogepant for prophylaxis of episodic migraine (ELEVATE)
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants with Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)
IRAS ID
279196
Contact name
Peter Goadsby
Contact email
Sponsor organisation
Allergan Limited
Eudract number
2019-003448-58
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
114780, IND
Duration of Study in the UK
1 years, 6 months, 29 days
Research summary
Migraine is a common health condition, affecting around 1 in 5 women and around 1 in 15 men. Migraine is typically characterised by a moderate to severe headache felt on 1 side of the head with nausea, vomiting, and/or sensitivity to light and sound.
Atogepant is an investigational drug, which means it is not approved for sale in the UK. The aim of this study is to assess how well atogepant works and is tolerated compared to placebo in the prevention of episodic migraine in participants who have previously failed other preventative treatments.
Participants will be will be assigned by chance (like tossing a coin or drawing straws) to 1 of the following study groups:
• Atogepant 30 mg once daily
• Atogepant 60 mg once daily
• Placebo (a medically inactive substance that looks like study medication, but does not contain the study medication)Neither participant, the study doctor or study staff will know whether they are taking atogepant or placebo during the study. However, this information is available should the study doctor decide it is needed for their health.
There will be a total of 8 study visits over a period of approximately 20 weeks. The participant may need to attend additional unscheduled visits for safety or other reasons.
The participant can either be male or female aged 18 to 80 years with at least 1-year history of migraine with or without aura.
Approximately 630 participants will take part worldwide and 55 participants in the UK across 8 NHS hospitals.
The participant will take 2 tablets of study treatment orally once a day at approximately the same time each day, with or without food.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0115
Date of REC Opinion
4 Nov 2020
REC opinion
Further Information Favourable Opinion