A Study to Learn About a Medicine Called Rimegepant in Adolescents With Chronic Migraine
Pediatric | Migraine | Headache | Chronic | Clinical TrialRimegepant is approved to treat migraine in adults but has not been studied in adolescents. The purpose of this study is to see if rimegepant is effective and safe for adolescents with chronic migraine.
Participants will receive one of 2 treatments: rimegepant or placebo. The study medication is given as a tablet taken every other day. Participants and the study doctor will not know whether they are receiving rimegepant or placebo in the first 12 weeks. After 12 weeks, all participants will receive rimegepant.
Participants will track their headaches daily in an eDiary. There are 7 visits in the first part of the study and 12 visits in the second part. These include questionnaires, bloodwork, and ECG.
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Participation Requirements
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Sex:
Female, Any, Male -
Eligible Ages:
12 to 17
Participation Criteria
Inclusion Criteria:
- aged 12-17 years
- 6-month history of chronic migraine (15 or more headache days per month)
Exclusion Criteria:
- continuous migraine in the last month
- history of psychiatric illness
- history of drug or alcohol abuse in the last 6-months
- history of severe drug allergy
- heart, kidney, or liver disease
- pregnancy or planned pregnancy
Study Location
University of Alberta
University of AlbertaEdmonton, Alberta
Canada
Contact Study Team
- Study Sponsored By
- University of Alberta
- Participants Required
- More Information
- Study ID:
Pro00148988