Efficacy and Safety Study of Rimegepant as Preventative Treatment of Migraine in Pediatric Subjects
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to ≤18 years of age
IRAS ID
1004840
Contact name
Tracy Nepomuceno
Contact email
Sponsor organisation
Biohaven Pharmaceuticals Holding Company Limited
Eudract number
2021-005246-15
Clinicaltrials.gov Identifier
Research summary
This clinical research study is evaluating an experimental drug called “rimegepant” in the pediatric population (children and adolescents). Rimegepant Nurtec® ODT is currently approved in the US for the acute treatment in adults with migraine and for the preventive treatment in adults with episodic migraine and more recently it has also received EMA approval (as Vydura®) in the EU and MHRA approval in the UK for the same indication in adults.
The main purpose of the study is to learn whether the study drug, rimegepant ODT (orally disintegrating tablet, a tablet that is taken by and dissolves in the mouth) is well tolerated and safe for the prevention of migraine compared to placebo in children and young people between the ages of 6 and 18 years.
Participation in this study consists of 4 phases (parts) over 76 weeks; a 4-week Screening/Observation Phase (2 on-site visits), a 12-week Double-blind Study Treatment Phase (5 on-site visits), a 52-week Open-label Extension Phase (1 telephone visit and 14 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 either rimegepant or placebo every other day. During this phase participants will have a 50% (1 in 2) chance of receiving the active study drug, rimegepant. During the Open-label extension phase, participants will receive active rimegepant ODT every other day. There is no placebo during this part of the study. The study will take place in approximately 100 study sites (medical facilities) in the US, Canada, EU and the UK. This study will screen approximately, 1,100 male and female participants, who are children at least 6 to 12 years old, and young people, who are at least 12 to ≤18 years old. The goal is to evaluate up to 640 participants who take the study drug. It is expected that up to 160 of these participants will be children and 480 will be young people.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
22/NE/0191
Date of REC Opinion
1 Dec 2022
REC opinion
Further Information Unfavourable Opinion