Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Conditions

• Pediatric Migraine

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Rimegepant/BHV3000 — DRUG
  BHV3000 (rimegepant) 75 mg or 50 mg ODT
• Matching placebo — DRUG
  Matching 75 mg or 50 mg ODT placebo

Study Details

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.

Key Dates

Start date

Jan 15, 2021

Status verified

Jun 2026

Primary completion

Jan 9, 2029

Completion

Jan 9, 2029

Study Design

Enrollment

2,100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: BHV3000 (active drug)
  BHV3000 (rimegepant) 75 mg or 50 mg ODT
• Placebo Comparator: Placebo
  Matching 75 mg or 50 mg ODT placebo

Primary Outcome Measure

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. [ Time Frame: 2 hours post-dose ]

Central Contacts

• Pfizer Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (169)

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