A Phase 3 interventional study of Rimegepant and Placebo in Migraine, sponsored by Pfizer. Recruiting at 93 sites in 7 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Pfizer · Phase 3, Interventional, and Prevention
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 640 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject has at least a 6 month history of migraine (with or without aura) and including the following:
Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to \<18 years; subjects must be less than 18 at the time of signing assent / consent.
3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Drug: Rimegepant
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Drug: Placebo
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Also known as: BHV3000
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Also known as: Matching Placebo
Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine
Reduction from baseline in mean number of migraine days per month
Time frame: 3 months (12 weeks)
Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine
Time frame: 3 months (12 weeks)
Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine.
Time frame: Weeks 1 through 4 of treatment
The mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine.
Time frame: Total score at week 12
Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
Time frame: 3 months (12 weeks)
Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month.
Measured over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
Time frame: 3 months (12 weeks)
Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days.
Measured in each month and over the course of the entire double-blind treatment phase in adolescents, children and adolescents and children combined.
Time frame: 3 months (12 weeks)
Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents.
This will be evaluated by the number of subjects with treatment related adverse events by severity.
Time frame: 72 Weeks
Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant.
Measured by discontinuations in treated subjects due to elevated liver function tests.
Time frame: 72 Weeks
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Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Rimegepant