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

RecruitingPhase 3

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

Who can join

Ages 18 to 45 · Women

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Pfizer · Participants: 723 · Started: Mar 11, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06641466

Locations in the U.S.

ArizonaMayo Clinic Hospital, Phoenix
Mayo Clinic Specialty Building, Phoenix
Mayo Clinic Arizona, Scottsdale
CaliforniaHope Clinical Research, Inc., Canoga Park
Axiom Research, Colton
Diablo Clinical Research, Inc., Walnut Creek
FloridaVIN - Aventura, Aventura
Velocity Clinical Research, Hallandale Beach, Hallandale
Jacksonville Center for Clinical Research, Jacksonville
GeorgiaUrban Family Practice Associates, Marietta
Clinical Research Atlanta, Stockbridge
IdahoSt Luke's Clinic - Neurology, Meridian
IndianaAlliance for Multispecialty Research - Medisphere Medical Research Center, Evansville
MichiganMichigan Headache & Neurological Institute, Ann Arbor
MissouriClinvest Headlands Llc, Springfield
St. Charles Clinical Research, Weldon Spring
NebraskaMcGill Family Practice, Papillion
NevadaExcel Clinical Research, LLC, Las Vegas
New YorkRochester Clinical Research, Rochester
Montefiore Medical Center, The Bronx
North CarolinaCarolina Women's Research and Wellness Center, Durham
OhioDayton Center for Neurological Disorders, Centerville
PennsylvaniaClinical Research of Philadelphia, Philadelphia
Thomas Jefferson University, Jefferson Headache Center, Philadelphia
Rhode IslandVelocity Clinical Research, Providence, East Greenwich
TennesseeAMR Clinical, Knoxville
Alliance for Multispecialty Research, LLC, Knoxville
Alliance for Multispecialty Research, LLC, Knoxville
TexasFutureSearch Trials of Neurology, Austin
FutureSearch Trials of Dallas, Dallas
VirginiaCharlottesville Medical Research, Charlottesville
MedStar Health Neurology/MedStar Georgetown Headache Center, McLean

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.