A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Purpose
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.
Condition
- Migraine
Eligibility
- Eligible Ages
- Between 12 Years and 17 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Rimegepant |
Experimental medicine under study |
|
|
Placebo Comparator Placebo |
A placebo does not have any medicine in it but looks just like the medicine being studied. |
|
Recruiting Locations
Ann Arbor, Michigan 48104
Winston-Salem, North Carolina 27157
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57108
Salt Lake City, Utah 84107
Salt Lake City, Utah 84117
More Details
- NCT ID
- NCT06616194
- Status
- Recruiting
- Sponsor
- Pfizer