Randomized Study in Children and Adolescents With Migraine: Acute Treatment
ConditionPediatric Migraine
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 groupsSponsors and collaborators
Source ClinicalTrials.gov