A Phase 4 Study in the Acute Treatment of Migraine in Adults unsuitable for Triptan Use
Research type
Research Study
Full title
BHV3000-406: A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
IRAS ID
1007008
Contact name
Peter Goadsby
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2022-001175-14
Clinicaltrials.gov Identifier
Research summary
The study will look at migraines in adults who are considered unsuitable for triptan use because of prior intolerance, lack of efficacy or contraindication (including a history of clinically relevant cardiovascular disease. The study is looking at Rimegepant, an approved medication for the acute treatment of migraine attacks and preventive treatment of episodic migraine.
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, also known as a warning sign) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition.
The double-blind, placebo-controlled, parallel group design to assess the efficacy of rimegepant in this population in a primary migraine attack is in accordance with international guidelines for such an evaluation. Additional information on the effectiveness and safety of rimegepant will also be obtained across additional attacks when used as needed in the 12-week open-label extension. The inclusion of the 12-week OLE Phase allows for the evaluation of safety and tolerability of rimegepant across multiple migraine attacks in a population of triptan-unsuitable adults. In addition, the OLE Phase allows for the potential to evaluate consistency of effect (as measured by improvement in quality of life [MQoL Question 16]), at the population level, among adults in need of effective alternative treatments for the management of acute migraine.
The study will be undertaken at NHS research sites, primary care/GP practices and private healthcare sites. Participation in the study will last approximately 24 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/0036
Date of REC Opinion
11 Aug 2023
REC opinion
Further Information Favourable Opinion