Phase 3 Randomized study in children and adolescents with migraine
Research type
Research Study
Full title
Phase 3, multicenter, randomized, double-blind, group sequential, placebo-controlled study to assess efficacy and safety of rimegepant for the treatment of migraine (with or without aura) in children and adolescents ≥ 6 to <18 years of age
IRAS ID
297615
Contact name
Prab Prabhakar
Contact email
Sponsor organisation
Biohaven Pharmaceuticals, Inc.
Eudract number
2020-003517-35
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
109886, IND number
Duration of Study in the UK
1 years, 8 months, 2 days
Research summary
This is a randomized, double-blind, group sequential, placebo-controlled study (with a single-blind placebo run-in phase) to assess efficacy and safety of rimegepant for the treatment of migraine (with or without aura) in children and adolescents ≥ 6 to <18 years of age.
This study will take place in approximately 190 sites in the United States and other additional countries with about 2,330 participants will be screened in order to achieve roughly 1,440 efficacy evaluable participants. Of the 1,440 efficacy evaluable participants, approximately 1,200 participants are expected to be adolescents and approximately 240 participants will be children under the age of 12.
The study is divided into 3 time periods: a screening period, a treatment period, and a follow-up period. During each study period, participants will have at least 1 visit with the study doctor at the centre. Study visits will generally last between 1 to 2 hours.
If the study doctor determines that a participant meets all the requirements to be in the study, they will be randomly assigned to receive one of the following treatments:
•Rimegepant
•Placebo
The chance of receiving rimegepant or placebo will vary during the study. At some point, participants will have a 50% (1 in 2) chance of receiving rimegepant and a 50% (1 in 2) chance of receiving placebo, and at some point, all participants will receive placebo.
Other study procedures include physical examination, blood and urine samples, vital signs, ECG and Questionnaires.REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0403
Date of REC Opinion
29 Jun 2021
REC opinion
Further Information Favourable Opinion