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Rimegepant/BHV3000

Phase 3

Pediatric Migraine | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment2,100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04649242Randomized Study in Children and Adolescents With Migraine: Acute TreatmentPHASE3 RECRUITING 2,100 — — Jan 15, 2021Jan 9, 2029Jun 5, 2026246 United States, Canada +7
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Study Endpoints
Primary Endpoints
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).

Secondary Endpoints
To compare rimegepant with placebo for pain freedom in children and adolescents combined.
2 hours post-dose
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in adolescents.
2 hours post-dose
To compare rimegepant with placebo on the probabilities of requiring rescue medication within in adolescents.
Within 24 hours and 48 hours of initial treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BHV3000 (active drug)ACTIVE_COMPARATORBHV3000 (rimegepant) 75 mg or 50 mg ODT
PlaceboPLACEBO_COMPARATORMatching 75 mg or 50 mg ODT placebo
Interventions
NameTypeDescription
Rimegepant/BHV3000DRUGBHV3000 (rimegepant) 75 mg or 50 mg ODT
Matching placeboDRUGMatching 75 mg or 50 mg ODT placebo
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Eligibility Criteria
Age Range6 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites246

Inclusion Criteria: 1. 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)/lega...

Countries:United StatesCanadaChinaJapanMexicoPolandSpainSwedenUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT04649242lastUpdatePostDate: changed
LOWJun 5, 2026NCT04649242lastUpdatePostDate: changed
LOWJun 5, 2026NCT04649242lastUpdatePostDate: changed
LOWJun 5, 2026NCT04649242lastUpdatePostDate: changed
LOWMay 26, 2026NCT04649242primaryCompletionDate: changed
LOWMay 24, 2026NCT04649242studyFirstPostDate: changed