Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorPfizer

About this trial

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.

Eligibility criteria

Qualifiers

History of migraine (with or without aura) for > 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).

History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting > 3 hours without treatment, and attacks occurring at intervals > 24 hours.

Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.

Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule], during the treatment phases.

Disqualifiers

History of cluster headache or hemiplegic migraine headache.

Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.

Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania.

History of suicidal behavior or major psychiatric disorder.

Trial design

Treatments tested in this trial

  • Rimegepant/BHV3000
  • Matching placebo

Treatment groups

2,100 Participants
are divided into 2 treatment groups

Locations

246
Canada
Kelowna Health & Memory CentreV1Y 5A8, Kelowna BCBritish Columbia, Canada
Diex Recherche Sherbrooke IncJ1L 0H8, SherbrookeQuebec, Canada
China
First Affiliated Hospital of Bengbu Medical College Neurology233000, BengbuAnhui, China
Anhui Provincial Hospital230000, HefeiAnhui, China

Sponsors and collaborators

Pfizer

Lead sponsor