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

What this study is about

The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks. Rimegepant is a tablet that dissolves when you put it on or under your tongue. The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day. Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months. In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period. Those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at all visits. Participants will have to complete a daily diary to record the migraine attacks.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• Xenoscience Inc, Phoenix, Arizona, United States
• Adult & Child Neurology Medical Associates, Long Beach, California, United States
• Children's Hospital Colorado, Aurora, Colorado, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
• Chicago Headache Center and Research Institute, Chicago, Illinois, United States
• Chicago Headache Center and Research Institute, Naperville, Illinois, United States
• New England Regional Headache Center, Worcester, Massachusetts, United States
• Michigan Headache & Neurological Institute, Ann Arbor, Michigan, United States
• Clinvest Headlands Llc, Springfield, Missouri, United States
• Rutgers University, New Brunswick, New Jersey, United States
• OnSite Clinical Solutions, Charlotte, North Carolina, United States
• Duke Health Center Creekstone, Durham, North Carolina, United States

+ 90 more sites.

Who to contact

Pfizer CT.gov Call Center · 1-800-718-1021 · ClinicalTrials.gov_Inquiries@pfizer.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06616194.