A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Phase 3
200
about 3 years
12–17
26 sites in AZ, CA, CO +12
What this study is about
Researchers are testing a treatment called rimegepant for adolescents with frequent migraine attacks. The trial will last 1112 days and involve comparing rimegepant to an inactive tablet, as well as long-term use of rimegepant. Participants will keep a daily diary of their migraines.
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)
Secondary: Efficacy of rimegepant relative to placebo measure as the mean change from baseline in the number of acute headache medication days per month, and acute migraine-specific medication days per month, Efficacy of rimegepant relative to placebo measured as mean change from baseline in the PedMIDAS total score, Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score, Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month, Efficacy of rimegepant relative to placebo measured the mean change from baseline in the number of headache days per month, Safety of rimegepant relative to placebo, and safety of rimegepant given for a long period of time measured as the number and percentage of participants with adverse event by severity and overall, Safety of rimegepant relative to placebo, and safety of rimegepant given for long period of time measured as the number and percentage of participants with liver-related adverse event and action taken
Neurology