A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Conditions

• Menstrual Migraine

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 45 Years

Healthy Volunteers

Not accepted

Interventions

• Rimegepant — DRUG
  Rimegepant 75 mg ODT for 7 days
• Placebo Comparator — DRUG
  Matching placebo oral disintegrating tablets for 7 days
• Standard of Care — DRUG
  Standard of care for acute treatment as needed
• Rimegepant — DRUG
  Rimegepant 75 mg ODT for acute treatment as needed

Study Details

The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks.

Key Dates

Start date

Mar 11, 2025

Status verified

Jun 2026

Primary completion

Nov 29, 2026

Completion

Mar 30, 2027

Study Design

Enrollment

723 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing
• Experimental: Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing
• Placebo Comparator: Placebo
• Active Comparator: Standard of Care

Primary Outcome Measure

Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [ Time Frame: 5 months (5 menstrual cycles) ]

Central Contacts

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

Locations (32)

Find similar trials in Phoenix, AZ

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