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Study details
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Efficacy and Safety of Rimegepant for Migraine Prevention in Children

Pfizer
NCT IDNCT05156398ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

640

Study length

about 11 years

Ages

6–17

Locations

52 sites in AR, CA, CO +19

About this study

Researchers are testing whether rimegepant, a medication, is effective and safe as a preventative treatment for migraine in children aged 6 to under 18 years. The trial will last approximately 3925 days and involve around 640 participants.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Placebo
  • 2.Take Rimegepant
PhasePhase 3
DrugRimegepant
Routeoral
Primary goalChange 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

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low5%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

rimegepant

Drug routes

oral (Disintegrating Oral Tablet)

Endpoints

Primary: 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

Secondary: 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., 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., 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., Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days., Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant., Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents., 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.

Body systems

Neurology