Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute 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 long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).
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. 2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening. 3. 1 or more migraine days requiring treatment during the Observation Phase. 4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit. 5. Ability to distinguish between migraine and other types of headaches. 6. Weight \> 15 kg. For EU countries only: Participants 12 to \< 18 years of age must have a body weight of \>25kg. 7. Adeq…
Interventions
- DrugRimegepant (PF-07899801)
Rimegepant 75 mg, 50 mg or 35 mg ODT
Locations (64)
- Advanced Research Center, Inc.Anaheim, California
- Adult & Child Neurology Medical AssociatesLong Beach, California
- Memorialcare Miller Children's & Women's Hospital Long BeachLong Beach, California
- Velocity Clinical Research - North HollywoodNorth Hollywood, California
- UC Davis Medical Center, Investigational Drug Service (IDS) PharmacySacramento, California
- Velocity Clinical Research- BanningSan Bernardino, California