Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

Conditions

• Acute Treatment of Migraine

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Rimegepant (PF-07899801) — DRUG
  Rimegepant 75 mg, 50 mg or 35 mg ODT

Study Details

The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).

Key Dates

Start date

Apr 28, 2021

Status verified

Jun 2026

Primary completion

Jul 31, 2030

Completion

Jul 31, 2030

Study Design

Enrollment

600 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Active
  rimegepant 75 mg, 50 mg or 35 mg ODT

Primary Outcome Measure

The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities [ Time Frame: 58 weeks ]

Central Contacts

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

Locations (116)

Find similar trials in Scottsdale, AZ

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