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

Phase 3RecruitingNCT06641466

Pfizer723 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

723

Conditions

Menstrual Migraine

Interventions

RimegepantDRUG

Rimegepant 75 mg ODT for 7 days

Placebo ComparatorDRUG

Matching placebo oral disintegrating tablets for 7 days

Standard of CareDRUG

Standard of care for acute treatment as needed

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participant has regular menstrual cycles ≥24 days and ≤34 days 2. A minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition 3. A history of menstrual migraine attacks of at least 3 months 4. Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening. 5. If the participant is receiving a permitted background continuous prophylactic migraine medication, the medication dose must be stable for at least 3 months prior to the Screening visit and, the dose is not expected to change during the course of the study Exclusion Criteria: 1. Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening 2. A diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months prior to Screening 3. History of retinal migraine, basilar migraine or hemiplegic migraine 4. Current diagnosis of schizophrenia, bipolar, or borderline personality disorder 5. Other pain syndromes (eg, fibromyalgia, complex regional pain syndrome), or significant neurological disorders (other than migraine), or other medical conditions (including endocrine and gynecological eg, severe dysmenorrhea

Locations (115)

Outcomes

Primary Outcomes

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

Change from Observation Period in the number of migraine days per the 5-day perimenstrual period