A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Public ClinicalTrials.gov record NCT06616194. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06616194
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 15, 2024 (Actual)
- Primary completion
- Aug 19, 2028 (Estimated)
- Completion
- Oct 13, 2029 (Estimated)
- Last update posted
- Jul 30, 2026
2024 – 2029
United States locations
- U.S. sites
- 27
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Xenoscience Inc | Phoenix | Arizona | 85004 | — |
| Adult & Child Neurology Medical Associates | Long Beach | California | 90806 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Chicago Headache Center and Research Institute | Chicago | Illinois | 60657 | — |
| Chicago Headache Center and Research Institute | Naperville | Illinois | 60563 | — |
| New England Regional Headache Center | Worcester | Massachusetts | 01609 | — |
| Michigan Headache & Neurological Institute | Ann Arbor | Michigan | 48104 | — |
| Clinvest Headlands Llc | Springfield | Missouri | 65807 | — |
| Rutgers University | New Brunswick | New Jersey | 08901 | — |
| OnSite Clinical Solutions | Charlotte | North Carolina | 28211 | — |
| Duke Health Center Creekstone | Durham | North Carolina | 27703 | — |
| Duke Lenox Baker Children's | Durham | North Carolina | 27705 | — |
| Duke Children's Health Center | Durham | North Carolina | 27710 | — |
| Wake Forest University Baptist Medical Center ( WFUBMC ) | Winston-Salem | North Carolina | 27157 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Avera Medical Group Pediatric Specialists | Sioux Falls | South Dakota | 57105 | — |
| Avera Research Institute - Sioux Falls | Sioux Falls | South Dakota | 57108 | — |
| Avera Medical Group Pediatrics - Dawley Farm | Sioux Falls | South Dakota | 57110 | — |
| Dell Children's Medical Center | Austin | Texas | 78723 | — |
| Headlands Research-El Paso | El Paso | Texas | 79902 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Wasatch Clinical Research, LLC | Salt Lake City | Utah | 84107 | — |
| Granger Medical Holladay - Holladay Clinic | Salt Lake City | Utah | 84117 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06616194, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2026 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06616194 live on ClinicalTrials.gov.