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NCT06616194 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
A Phase 3 study of Migraine, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT06616194 is a Phase 3 study of Migraine that is actively recruiting participants, run by Pfizer. The registered enrollment target is 200 participants, below the 356-participant average among 102 other Migraine trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT06616194, a Phase 3 study of Migraine, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rimegepant
Study Locations (20)
North Carolina
- OnSite Clinical Solutions - Charlotte
- Duke Health Center Creekstone - Durham
- Duke Lenox Baker Children's - Durham
- Duke Children's Health Center - Durham
- Wake Forest University Baptist Medical Center ( WFUBMC ) - Winston-Salem
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
- Chicago Headache Center and Research Institute - Chicago
- Chicago Headache Center and Research Institute - Naperville
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Cleveland Clinic - Cleveland
South Dakota
- Avera Medical Group Pediatric Specialists - Sioux Falls
- Avera Research Institute - Sioux Falls - Sioux Falls
Arizona
- Xenoscience Inc - Phoenix
California
- Adult & Child Neurology Medical Associates - Long Beach
Colorado
- Children's Hospital Colorado - Aurora
Massachusetts
- New England Regional Headache Center - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-11-15 |
| Est. Completion | 2027-12-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06616194
The ClinicalTrials.gov registry entry for NCT06616194 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 356-participant average among 102 other Migraine trials with a reported enrollment target (44% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06616194 reports 20 study locations spanning 12 distinct geographic areas - top geographies include North Carolina, Illinois, Ohio.
Frequently Asked Questions
What is clinical trial NCT06616194 about?
NCT06616194 is a clinical study titled "A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine". 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) ...
What is the current status of trial NCT06616194?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2024-11-15. Estimated completion is 2027-12-02.
What conditions does trial NCT06616194 study?
This clinical trial studies the following conditions: Migraine.
What interventions are being tested in trial NCT06616194?
The interventions under investigation include: Placebo (DRUG), Rimegepant (DRUG).
Who is sponsoring clinical trial NCT06616194?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06616194 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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