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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Rimegepant/BHV3000
DrugBHV3000 (rimegepant) 75 mg or 50 mg ODT
Matching placebo
DrugMatching 75 mg or 50 mg ODT placebo
Treatment groups
2,100 Participants
are divided into 2 treatment groupsGroup A: BHV3000 (active drug)Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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).
Time frame
2 hours post-doseSecondary outcomes
1
To compare rimegepant with placebo for pain freedom in children and adolescents combined.
Pain freedom will be assessed in children and adolescents (≥ 6 to \< 18 years of age) using a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Pain freedom will be assessed in children (\> 6 to \< 12 years of age) using the 5-Face VAS (Face 5 = 'severe pain', Faces 4 and 3 = 'moderate pain', Face 2 = 'mild pain', Face 1 = 'no pain').
Time frame
2 hours post-dose2
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in adolescents.
Freedom from MBS (nausea, phonophobia or photophobia) will be measured using a binary scale (0=absent, 1=present).
Time frame
2 hours post-dose3
To compare rimegepant with placebo on the probabilities of requiring rescue medication within in adolescents.
Use of rescue medication will be assessed using the numbers of participants that take rescue medication.
Time frame
Within 24 hours and 48 hours of initial treatment4
To compare rimegepant with placebo on sustained pain freedom in adolescents.
Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.
Time frame
2 to 24 hours post-dose Source ClinicalTrials.gov