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
Pfizer
Summary
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.
Eligibility
- Age range
- 6–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject has at least a 6 month history of migraine (with or without aura) and including the following: 1. 14 or less headache days per month during the 3 month period prior to the Screening Visit 2. 6 or more migraine days during the Observation Period 3. 14 or less headache days during the Observation Period 4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit 5. Ab…
Interventions
- DrugRimegepant
Rimegepant 75mg or 50mg (2 X 25mg) ODT
- DrugPlacebo
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Locations (44)
- Advanced Investigative Medicine, Inc.Hawthorne, California
- Velocity Clinical Research San DiegoLa Mesa, California
- Colorado Springs Neurological AssociatesColorado Springs, Colorado
- Advanced Neurosciences Research, LLCFort Collins, Colorado
- Accel Research Sites Network - Edgewater Clinical Research UnitEdgewater, Florida
- Direct Helpers Research CenterHialeah, Florida