Efficacy and Safety Study of Rimegepant in Episodic Migraine with Multiple Dosing Regimens
Research type
Research Study
Full title
A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention with Multiple Dosing Regimens
IRAS ID
1004841
Contact name
Jeremy Cordova
Contact email
Sponsor organisation
Biohaven Pharmaceuticals Holding Company Limited
Eudract number
2021-005239-22
Clinicaltrials.gov Identifier
Research summary
This clinical research study involves a drug called “rimegepant”. Rimegepant’s brand name in the US is Nurtec® ODT (orally disintegrating tablet, which means a tablet that is taken by and dissolves in the mouth). It is currently approved in the US for the acute treatment in adults with migraine and for the preventive treatment in adults with episodic migraine.
The purpose of this study is to further evaluate how well the drug works in preventing episodic migraine compared to nothing when taken daily, or every other day. Additionally, this study is evaluating if the study drug is well tolerated and safe.
Participation in this study consists of 4 phases (parts) over 36 weeks; a 4-week Screening/Observation Phase (2 on-site visits), a 12-week Double-blind Study Treatment Phase (5 on-site visits), a 12-week Open-label Extension Phase (1 telephone visit and 4 on-site visits) and an 8-week Follow-up Phase (2 on-site visits).
During the Double-blind study treatment phase, participants will be randomly assigned (by chance, like the flip of a coin) to receive treatment. One group will take a 75 mg rimegepant ODTdaily, the second group will alternate between a 75 mg rimegepant ODT and a placebo, and the third group will only take the placebo daily. During this phase participants will have a 66% (2 in 3) chance of receiving the active study drug, rimegepant. During the Open-label extension phase, participants will receive active rimegepant ODT daily. There is no placebo during this part of the study.
The study will take place in approximately 125 study sites (medical facilities) in the US, Canada, European countries, United Kingdom (UK), and Israel. This study will screen approximately 2000 male and female participants who are at least 18 years of age at the time of signing and dating consent. The goal is to evaluate approximately 660 participants who take study drug, with up to 220 participants in each treatment group.
REC name
London - Westminster Research Ethics Committee
REC reference
22/LO/0454
Date of REC Opinion
6 Sep 2022
REC opinion
Further Information Favourable Opinion