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Investigating the effects of rimegepant on frequent migraines in adolescents

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

Phase 3 Interventional Pfizer · NCT06616194

This study tests if a new dissolvable tablet called rimegepant can help teenagers who get frequent migraines feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment200 (estimated)
Ages12 Years to 17 Years
SexAll
SponsorPfizer Industry-sponsored
Locations48 sites (Long Beach, California and 47 other locations)
Trial IDNCT06616194 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of rimegepant, a dissolvable tablet, in adolescents experiencing frequent migraine attacks. Participants will be enrolled if they have a history of at least 15 headache days per month, including 8 days of migraine. The study will be conducted in two phases, with the first phase involving a comparison between rimegepant and a placebo over three months. The second phase will continue to monitor participants who respond positively to the treatment.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12-17 with a documented history of frequent migraines.

Not a fit: Patients with uncontrolled psychiatric conditions or those currently participating in another clinical trial may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for adolescents suffering from frequent migraines.

How similar studies have performed: Previous studies have shown promising results with similar migraine treatments, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Long Beach, California and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MigraineChronic migraineadolescentsrimegepant,cgrp
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.