A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Launched by PFIZER · Sep 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called rimegepant, which is designed to help adolescents who experience frequent migraines. To be eligible for the study, participants should be between 12 and 17 years old and have a history of migraines for at least six months. This means they should have 15 or more headache days each month, with at least 8 of those days being migraines that last anywhere from 4 to 72 hours if not treated.

Participants in the study will first take either rimegepant or a placebo (an inactive pill that looks the same) for three months. This will help researchers see how well rimegepant works and if it is safe. After that, everyone who remains in the study will take rimegepant for another year. Throughout the trial, participants will have regular visits to the study clinic and will keep a daily diary to track their migraine attacks. This study aims to gather important information that could help improve treatment for adolescents suffering from migraines.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • At least a 6 month history of migraine (with or without aura)
• • 15 or more headache days/month
• • 8 or more migraine days/month
• • Migraine lasting 4-72 hours if untreated
• Exclusion Criteria:
• • Unrelenting headache
• • Current psychiatric condition uncontrolled or untreated
• • History of suicidal behavior or the subject is at risk of self-harm
• • History of alcohol abuse and/or illicit drug use
• • History of severe drug allergy
• • Use of more than one medication for migraine prevention/prophylaxis
• • Participation in another clinical trial at the same time