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Recruiting Phase 3

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

NCT06641466 · tracked via the Priya Life Science Denmark tracker
Sponsor
Phase
Phase 3
Started
2025-03-11
Last updated
2026-07-09

Condition(s) studied

Menstrual Migraine

Investigational drug(s) / intervention(s)

Rimegepant →Placebo ComparatorStandard of CareRimegepant →

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

Study 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

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 — 5 months (5 menstrual cycles)
    Change from Observation Period in the number of migraine days per the 5-day perimenstrual period

Trial sites (123)

FacilityCityRegionStatus
Mayo Clinic Hospital Phoenix Arizona Recruiting
Mayo Clinic Specialty Building Phoenix Arizona Recruiting
Mayo Clinic Arizona Scottsdale Arizona Recruiting
Hope Clinical Research, Inc. Canoga Park California Recruiting
Axiom Research Colton California Recruiting
Diablo Clinical Research, Inc. Walnut Creek California Recruiting
VIN - Aventura Aventura Florida Recruiting
Velocity Clinical Research, Hallandale Beach Hallandale Florida Recruiting
Jacksonville Center for Clinical Research Jacksonville Florida Recruiting
Urban Family Practice Associates Marietta Georgia Recruiting
Clinical Research Atlanta Stockbridge Georgia Recruiting
St Luke's Clinic - Neurology Meridian Idaho Recruiting
Alliance for Multispecialty Research - Medisphere Medical Research Center Evansville Indiana Recruiting
Michigan Headache & Neurological Institute Ann Arbor Michigan Recruiting
Clinvest Headlands Llc Springfield Missouri Recruiting
St. Charles Clinical Research Weldon Spring Missouri Recruiting
McGill Family Practice Papillion Nebraska Recruiting
Excel Clinical Research, LLC Las Vegas Nevada Recruiting
Rochester Clinical Research Rochester New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Carolina Women's Research and Wellness Center Durham North Carolina Recruiting
Dayton Center for Neurological Disorders Centerville Ohio Recruiting
Thomas Jefferson University, Jefferson Headache Center Philadelphia Pennsylvania Recruiting
Clinical Research of Philadelphia Philadelphia Pennsylvania Recruiting
Velocity Clinical Research, Providence East Greenwich Rhode Island Recruiting
Alliance for Multispecialty Research, LLC Knoxville Tennessee Recruiting
AMR Clinical Knoxville Tennessee Recruiting
Alliance for Multispecialty Research, LLC Knoxville Tennessee Recruiting
FutureSearch Trials of Neurology Austin Texas Recruiting
FutureSearch Trials of Dallas Dallas Texas Recruiting
Charlottesville Medical Research Charlottesville Virginia Recruiting
MedStar Health Neurology/MedStar Georgetown Headache Center McLean Virginia Recruiting
Fundación para la lucha contra las enfermedades neurológicas de la infancia CABA Buenos Aires Recruiting
IDIM - Instituto de Investigaciones Metabólicas Buenos Aires Buenos Aires F.D. Recruiting
Mautalen Salud e Investigación Buenos Aires Buenos Aires F.D. Recruiting
Hospital Cordoba Cordoba Capital Córdoba Province Recruiting
Sanatorio del Sur San Miguel de Tucumán Tucumán Province Recruiting
Clínica Privada Gallia Córdoba Argentina Recruiting
CaRe Clinic Red Deer Alberta Recruiting
OCT Research ULC Kelowna British Columbia Recruiting

+ 83 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06641466 on ClinicalTrials.gov ↗ ← All trials in Denmark