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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Menstrual Migraine

In brief

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.

Key facts

Study ID

NCT06641466

Run by

Pfizer

People needed

723

Starts

2025-03-11

Expected to finish

2027-03-30

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participant has regular menstrual cycles ≥24 days and ≤34 days
• 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
• A history of menstrual migraine attacks of at least 3 months
• 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.
• 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

You may not qualify if…

• Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
• 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
• History of retinal migraine, basilar migraine or hemiplegic migraine
• Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
• 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

Where it is running

• Mayo Clinic Specialty Building — Phoenix, Arizona, United States (enrolling)
• Mayo Clinic Arizona — Scottsdale, Arizona, United States (enrolling)
• Hope Clinical Research, Inc. — Canoga Park, California, United States (enrolling)
• Axiom Research — Colton, California, United States (enrolling)
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States (enrolling)
• VIN - Aventura — Aventura, Florida, United States (enrolling)
• Velocity Clinical Research, Hallandale Beach — Hallandale, Florida, United States (enrolling)
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (enrolling)
• Urban Family Practice Associates — Marietta, Georgia, United States (enrolling)
• Clinical Research Atlanta — Stockbridge, Georgia, United States (enrolling)
• St Luke's Clinic - Neurology — Meridian, Idaho, United States (enrolling)
• Alliance for Multispecialty Research - Medisphere Medical Research Center — Evansville, Indiana, United States (enrolling)
• Michigan Headache & Neurological Institute — Ann Arbor, Michigan, United States (enrolling)
• Clinvest Headlands Llc — Springfield, Missouri, United States (enrolling)
• St. Charles Clinical Research — Weldon Spring, Missouri, United States (enrolling)
• McGill Family Practice — Papillion, Nebraska, United States (enrolling)
• Excel Clinical Research, LLC — Las Vegas, Nevada, United States (enrolling)
• Rochester Clinical Research — Rochester, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Carolina Women's Research and Wellness Center — Durham, North Carolina, United States (enrolling)
• Dayton Center for Neurological Disorders — Centerville, Ohio, United States (enrolling)
• Thomas Jefferson University, Jefferson Headache Center — Philadelphia, Pennsylvania, United States (enrolling)
• Clinical Research of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Velocity Clinical Research, Providence — East Greenwich, Rhode Island, United States (enrolling)
• Mayo Clinic Hospital — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.