Efficacy and Safety of Rimegepant for Migraine Prevention in Children
Phase 3
640
about 11 years
6–17
52 sites in AR, CA, CO +19
What this study is about
Researchers are testing whether rimegepant, a medication, is effective and safe as a preventative treatment for migraine in children aged 6 to under 18 years. The trial will last approximately 3925 days and involve around 640 participants.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Placebo
- 2.Take Rimegepant
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
rimegepant
oral (Disintegrating Oral Tablet)
Primary: Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine
Secondary: Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine., Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine., Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month., Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days., Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant., Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents., The mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine.
Neurology