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

Description

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.

Conditions

Menstrual Migraine

Study Overview

Study Details

Study 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.

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, PARALLEL GROUP STUDY TO INVESTIGATE INTERMITTENT PREVENTION OF MENSTRUAL MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN WOMEN PARTICIPANTS 18 TO 45 YEARS OF AGE

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

Condition
Menstrual Migraine
Intervention / Treatment

-

Contacts and Locations

Walnut Creek

Diablo Clinical Research, Inc., Walnut Creek, California, United States, 94598

Hallandale Beach

Velocity Clinical Research, Hallandale Beach, Hallandale Beach, Florida, United States, 33009

Weldon Spring

St. Charles Clinical Research, Weldon Spring, Missouri, United States, 63304

Papillion

McGill Family Practice, Papillion, Nebraska, United States, 68046

Rochester

Rochester Clinical Research, LLC, Rochester, New York, United States, 14609

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2026-12-01