Phase 4 study of Rimegepant for the Prevention of Migraine in Adults
Research type
Research Study
Full title
BHV3000-407: A Phase 4, Randomized, Doubleblind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults with a History of Inadequate Response to Oral Preventive Medications.
IRAS ID
1007017
Contact name
Peter Goadsby
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2022-001176-34
Research summary
This is a phase 4 multicenter, randomised, double-blind, placebo-controlled evaluation of the safety and efficacy of rimegepant (75 mg ODT taken every other day) for prophylaxis in adults with a history of inadequate response to a variety of available oral migraine-preventive medications from different mechanistic classes.
This is a phase 4 multi-centre, randomised double-blind placebo-Controlled, Efficacy and Tolerability study in male and female subjects aged between 18 - 65 years of age with a minimum of 1-year documented history of migraine attacks (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition.
During the DBT Phase, subjects will be instructed that they must take one tablet of blinded study drug every other calendar day (EOD). If subjects have a migraine during the DBT Phase, permitted acute migraine medication (see Section 17.5, Appendix 5) may be used, as needed, and in accordance with the standard of care, to manage acute attacks regardless if the migraine occurs on a study drug dosing day or non-dosing day. Study drug is NOT to be used for the treatment of acute migraine attacks, but regularly dosed EOD, in accordance with the protocol.
The study will be undertaken at NHS research sites, primary care/GP practices and private healthcare sites. Participation in the study will last approximately 18 weeks and will undergo approximately 8 study visits to the study clinic or hospital.REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0011
Date of REC Opinion
11 Aug 2023
REC opinion
Further Information Favourable Opinion