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A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT06641466•Pfizer

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

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 (122)

Mayo Clinic Hospital

Phoenix, Arizona, United States

Mayo Clinic Specialty Building

Phoenix, Arizona, United States

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Hope Clinical Research, Inc.

Canoga Park, California, United States

Axiom Research

Colton, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

VIN - Aventura

Aventura, Florida, United States

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Urban Family Practice Associates

Marietta, Georgia, United States

Key Dates

Start Date

March 11, 2025

Primary Completion Date

November 29, 2026

Completion Date

March 30, 2027

Last Updated

March 20, 2026

Enrollment

723

ESTIMATED participants

Conditions

Menstrual Migraine

Interventions

Rimegepant

DRUG

Placebo Comparator

DRUG

Standard of Care

DRUG

Rimegepant

DRUG

Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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UNKNOWN

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TERMINATED

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine

Detecting Auricular Points in MMG by a Novel APD ( APD-MMG )

Frovatriptan and Menstrual Migraine

Saccadometry in Primary Headache Syndromes

CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Menstrual Migraine Before and After Treximet