Rimegepant for Acute Migraine Treatment in Children and Adolescents

This study is looking for children and adolescents aged 6 to 17 who experience migraines to test a medication called rimegepant (also known as BHV3000). The goal is to see if rimegepant, at either a 75 mg or 50 mg dose, can effectively stop migraine pain compared to a placebo (an inactive substance). Researchers will measure how many participants are completely pain-free two hours after taking the medication. You could be eligible if you have a history of migraines for at least six months. The study is currently unclear on its recruitment status.

Study design
This is an interventional, randomized study involving 2100 participants. It compares rimegepant to a matching placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 2 hours post-dose, but overall follow-up duration is not specified.

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NCT04649242

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Recruiting
PHASE3Ages 6–17InterventionalTreatment
Pfizer
~2,100 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Rimegepant/BHV3000Matching placebo

At a glance

Recruiting sites
129 of 245 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain.
Measured over 2 hours post-dose
Pediatric Migraine
245 sites across 78 states
California20
Texas19
Florida18
New York16
Ohio7
Virginia7
Poland7
Montana6
  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

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  • To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain.2 hours post-dose

    Pain freedom will be assessed in adolescent population (≥ 12 to \< 18 years of age) on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).