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Randomized Study in Children and Adolescents With Migraine: Acute Treatment

NCT04649242 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2100

Last updated 2026-05-20

No results posted yet for this study

Summary

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.

Conditions

  • Pediatric Migraine

Interventions

DRUG

Rimegepant/BHV3000

BHV3000 (rimegepant) 75 mg or 50 mg ODT

DRUG

Matching placebo

Matching 75 mg or 50 mg ODT placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2029-01-09
Completion
2029-01-09
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • Japan
  • Mexico
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04649242 on ClinicalTrials.gov