NCT06616194 A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
| NCT ID | NCT06616194 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2026-10-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2024-11-15 with a primary completion date of 2026-10-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT06616194 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06616194 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT06616194 currently recruiting?
Yes, NCT06616194 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT06616194 trial being conducted?
This trial is being conducted at Phoenix, United States, Long Beach, United States, Aurora, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT06616194 clinical trial?
NCT06616194 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 200 participants.
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