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
Pfizer
Summary
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
Eligibility
- Age range
- 6–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. History of migraine (with or without aura) for \> 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s). 2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \> 3 hours without treatment, and attacks occurring at intervals \> 24 hours. 3. Prophylactic migraine medication are permitted if the dose has been stable for…
Interventions
- DrugRimegepant/BHV3000
BHV3000 (rimegepant) 75 mg or 50 mg ODT
- DrugMatching placebo
Matching 75 mg or 50 mg ODT placebo
Locations (109)
- Advanced Research Center, Inc.Anaheim, California
- Adult & Child Neurology Medical AssociatesCosta Mesa, California
- Memorial Health ServicesFountain Valley, California
- Adult & Child Neurology Medical AssociatesLong Beach, California
- Miller Children's & Women's Hospital Long BeachLong Beach, California
- Velocity Clinical Research - North HollywoodNorth Hollywood, California