Recruiting
Phase 3

Rimegepant

Sponsor:

Pfizer

Code:

NCT06641466

Conditions

Menstrual Migraine

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Rimegepant

Placebo Comparator

Standard of Care

Rimegepant

Study Details

Brief 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.

Conditions

Menstrual Migraine

Study ID

NCT06641466

Start date

Mar 11, 2025

Status verified date

Jul, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Nov 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

723 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Rimegepant

Rimegepant 75 mg ODT for 7 days

Placebo Comparator

Matching placebo oral disintegrating tablets for 7 days

Standard of Care

Standard of care for acute treatment as needed

Rimegepant

Rimegepant 75 mg ODT for acute treatment as needed

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 and Locations

Central contacts

Pfizer CT.gov Call Center

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

Locations

Mayo Clinic Hospital

Recruiting

Phoenix, Arizona, United States, 85054

Mayo Clinic Specialty Building

Recruiting

Phoenix, Arizona, United States, 85054

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Hope Clinical Research, Inc.

Recruiting

Canoga Park, California, United States, 91303

Axiom Research

Recruiting

Colton, California, United States, 92324

Diablo Clinical Research, Inc.

Recruiting

Walnut Creek, California, United States, 94598

VIN - Aventura

Recruiting

Aventura, Florida, United States, 33180

Velocity Clinical Research, Hallandale Beach

Recruiting

Hallandale, Florida, United States, 33009

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Urban Family Practice Associates

Recruiting

Marietta, Georgia, United States, 30067

Clinical Research Atlanta

Recruiting

Stockbridge, Georgia, United States, 30281

St Luke's Clinic - Neurology

Recruiting

Meridian, Idaho, United States, 83642

Alliance for Multispecialty Research - Medisphere Medical Research Center

Recruiting

Evansville, Indiana, United States, 47714

Michigan Headache & Neurological Institute

Recruiting

Ann Arbor, Michigan, United States, 48104

Clinvest Headlands Llc

Recruiting

Springfield, Missouri, United States, 65807

St. Charles Clinical Research

Recruiting

Weldon Spring, Missouri, United States, 63304

McGill Family Practice

Recruiting

Papillion, Nebraska, United States, 68046

Excel Clinical Research, LLC

Recruiting

Las Vegas, Nevada, United States, 89109

Rochester Clinical Research

Recruiting

Rochester, New York, United States, 14609

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Carolina Women's Research and Wellness Center

Recruiting

Durham, North Carolina, United States, 27713

Dayton Center for Neurological Disorders

Recruiting

Centerville, Ohio, United States, 45459

Thomas Jefferson University, Jefferson Headache Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Clinical Research of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19114

Velocity Clinical Research, Providence

Recruiting

East Greenwich, Rhode Island, United States, 02818

Alliance for Multispecialty Research, LLC

Recruiting

Knoxville, Tennessee, United States, 37909

AMR Clinical

Recruiting

Knoxville, Tennessee, United States, 37909

Alliance for Multispecialty Research, LLC

Recruiting

Knoxville, Tennessee, United States, 37920

FutureSearch Trials of Neurology

Recruiting

Austin, Texas, United States, 78731

FutureSearch Trials of Dallas

Recruiting

Dallas, Texas, United States, 75251

Charlottesville Medical Research

Recruiting

Charlottesville, Virginia, United States, 22911

MedStar Health Neurology/MedStar Georgetown Headache Center

Recruiting

McLean, Virginia, United States, 22101

CaRe Clinic

Recruiting

Red Deer, Alberta, Canada, T4P 1K4

OCT Research ULC

Recruiting

Kelowna, British Columbia, Canada, V1Y 1Z9

Centre for Neurology Studies

Recruiting

Surrey, British Columbia, Canada, V3V 0E8

Centricity Research Halifax Multispecialty

Recruiting

Halifax, Nova Scotia, Canada, B3S 1N2

Aggarwal and Associates Limited

Recruiting

Brampton, Ontario, Canada, L6T 0G1

Bluewater Clinical Research Group Inc.

Recruiting

Sarnia, Ontario, Canada, N7T 4X3

Centre de Recherche Saint-Louis inc.

Recruiting

Lévis, Quebec, Canada, G6W 0Y3

More Information

Sponsor

Pfizer

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Pfizer on 2026-07-09.