A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine (NCT06616194)
AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE
🩺 Plain-English Summary (8th-Grade Level)
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: Review the eligibility criteria below.
Location: Xenoscience Inc — Phoenix, Arizona
Age range: 12 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (102 Sites)
Showing the first 25 of 102 sites.
- Xenoscience Inc — Phoenix, Arizona
- Adult & Child Neurology Medical Associates — Long Beach, California
- Children's Hospital Colorado — Aurora, Colorado
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
- Chicago Headache Center and Research Institute — Chicago, Illinois
- Chicago Headache Center and Research Institute — Naperville, Illinois
- New England Regional Headache Center — Worcester, Massachusetts
- Michigan Headache & Neurological Institute — Ann Arbor, Michigan
- Clinvest Headlands Llc — Springfield, Missouri
- Rutgers University — New Brunswick, New Jersey
- OnSite Clinical Solutions — Charlotte, North Carolina
- Duke Health Center Creekstone — Durham, North Carolina
- Duke Lenox Baker Children's — Durham, North Carolina
- Duke Children's Health Center — Durham, North Carolina
- Wake Forest University Baptist Medical Center ( WFUBMC ) — Winston-Salem, North Carolina
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Cleveland Clinic — Cleveland, Ohio
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania
- Avera Medical Group Pediatric Specialists — Sioux Falls, South Dakota
- Avera Research Institute - Sioux Falls — Sioux Falls, South Dakota
- Avera Medical Group Pediatrics - Dawley Farm — Sioux Falls, South Dakota
- Dell Children's Medical Center — Austin, Texas
- Headlands Research-El Paso — El Paso, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas
- Wasatch Clinical Research, LLC — Salt Lake City, Utah
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.