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
2 other identifiers
interventional
723
15 countries
122
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2025
122 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedStudy Start
First participant enrolled
March 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2027
April 16, 2026
April 1, 2026
1.7 years
October 11, 2024
April 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Change from Observation Period in the number of migraine days per the 5-day perimenstrual period
5 months (5 menstrual cycles)
Secondary Outcomes (11)
Mean change from the Observation Period in number of headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
5 months (5 menstrual cycles)
Percentage of participants with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase (50% responder)
5 months (5 menstrual cycles)
Mean change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
5 months (5 menstrual cycles)
Mean change from the Observation Period in number of acute migraine-specific medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
5 months (5 menstrual cycles)
Mean change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
5 months (5 menstrual cycles)
- +6 more secondary outcomes
Study Arms (4)
Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing
EXPERIMENTALRimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing
EXPERIMENTALPlacebo
PLACEBO COMPARATORStandard of Care
ACTIVE COMPARATORInterventions
Rimegepant 75 mg ODT for 7 days
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (122)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Mayo Clinic Specialty Building
Phoenix, Arizona, 85054, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Hope Clinical Research, Inc.
Canoga Park, California, 91303, United States
Axiom Research
Colton, California, 92324, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
VIN - Aventura
Aventura, Florida, 33180, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Urban Family Practice Associates
Marietta, Georgia, 30067, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
St Luke's Clinic - Neurology
Meridian, Idaho, 83642, United States
Alliance for Multispecialty Research - Medisphere Medical Research Center
Evansville, Indiana, 47714, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinvest Headlands Llc
Springfield, Missouri, 65807, United States
St. Charles Clinical Research
Weldon Spring, Missouri, 63304, United States
McGill Family Practice
Papillion, Nebraska, 68046, United States
Excel Clinical Research, LLC
Las Vegas, Nevada, 89109, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459, United States
Thomas Jefferson University, Jefferson Headache Center
Philadelphia, Pennsylvania, 19107, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909, United States
AMR Clinical
Knoxville, Tennessee, 37909, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
ChronicleBio
West Valley City, Utah, 84119, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
MedStar Health Neurology/MedStar Georgetown Headache Center
McLean, Virginia, 22101, United States
Fundación para la lucha contra las enfermedades neurológicas de la infancia
CABA, Buenos Aires, 1428, Argentina
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires, Buenos Aires, C1012AAR, Argentina
Mautalen Salud e Investigación
Buenos Aires, Buenos Aires F.D., C1128AAF, Argentina
Hospital Cordoba
Cordoba Capital, Córdoba Province, 5004, Argentina
Sanatorio del Sur
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Clínica Privada Gallia
Córdoba, 5021, Argentina
CaRe Clinic
Red Deer, Alberta, T4P 1K4, Canada
OCT Research ULC
Kelowna, British Columbia, V1Y 1Z9, Canada
Centre for Neurology Studies
Surrey, British Columbia, V3V 0E8, Canada
Centricity Research Halifax Multispecialty
Halifax, Nova Scotia, B3S 1N2, Canada
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3, Canada
Centre de Recherche Saint-Louis inc.
Lévis, Quebec, G6W0M5, Canada
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Hebei General Hospital
Shijiazhuang, Hebei, 050051, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Shaanxi provincial people's hospital
Xi'an, Shaanxi, 710068, China
Xianyang Hospital of Yan'an University
Xianyang, Shaanxi, 712000, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Qingdao Central Hospital, University of Health and Rehabilitation Sciences
Qingdao, 266042, China
Shanghai East Hospital
Shanghai, 200123, China
Rigshospitalet, Glostrup
Glostrup Municipality, 2600, Denmark
Region Midtjylland, Regionshospitalet Viborg
Viborg, 8800, Denmark
Klinische Forschung Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, 19055, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, 10117, Germany
FutureMeds GmbH
Berlin, 10629, Germany
Neurologie Berlin
Berlin, 12163, Germany
Lalitha PVS Institute of Medical Sciences
Guntur, Andhra Pradesh, 522001, India
Marengo CIMS Hospital, Ahmedabad
Ahmedabad, Gujarat, 380060, India
Mallikatta Neuro Centre
Mangaluru, Karnataka, 575002, India
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
Mumbai, Maharashtra, 400008, India
Getwell Hospital and Research Institute
Nagpur, Maharashtra, 440012, India
Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute
Nashik, Maharashtra, 422005, India
Jawahar Lal Nehru Medical College
Ajmer, Rajasthan, 305001, India
Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso
Avezzano, L'aquila, 67051, Italy
Fondazione Policlinico Universitario Campus Biomedico
Rome, Lazio, 00128, Italy
Ospedale Bellaria- Azienda USL di Bologna
Bologna, 40139, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Fondazione Istituto Neurologico C. Mondino
Pavia, 27100, Italy
IRCCS San Raffaele Roma
Roma, 00166, Italy
Konan Medical Center
Kobe, Hyōgo, 658-0064, Japan
Tatsuoka Neurology Clinic
Kyoto-shi Shimogyo-ku, Kyoto, 600-8811, Japan
Sendai Headache and Neurology Clinic
Sendai, Miyagi, 982-0014, Japan
Tokyo Headache Clinic
Shibuya-ku, Tokyo, 151-0051, Japan
Nagaseki Headache Clinic
Kai, Yamanashi, 400-0124, Japan
Tanaka Neurosurgery&Headache Clinic
Kagoshima, 890-0052, Japan
Tanaka Neurosurgical Clinic
Kagoshima, 892-0844, Japan
Centro de Investigación Médico Biológica y Terapia Avanzada
Guadalajara, Jalisco, 44130, Mexico
Clinstile, S.A. de C.V.
Mexico City, Mexico City, 06700, Mexico
Medical Care and Research SA de CV
Mérida, Yucatán, 97070, Mexico
San Peregrino Unidad de Investigación
Aguascalientes, 20230, Mexico
Operadora Unidad de Investigación en Salud de Chihuahua
Chihuahua City, 31203, Mexico
PCR Cuautitlán Izcalli
Cuautitlán Izcalli, 54750, Mexico
Clinical Research Institute S.C.
Tlalnepantla, 54055, Mexico
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532 SZ, Netherlands
Isala Klinieken Stichting
Zwolle, Overijssel, 8025 AB, Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, South Holland, 2333 ZA, Netherlands
Specjalistyczne Gabinety Sp. z o. o.
Krakow, Lesser Poland Voivodeship, 30-539, Poland
Instytut Zdrowia Dr Boczarska Jedynak
Oświęcim, Lesser Poland Voivodeship, 32-600, Poland
MIGRE Polskie Centrum Leczenia Migreny
Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
NZOZ Neuromed M.i M. Nastaj
Lublin, Lublin Voivodeship, 20-064, Poland
Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej
Lublin, Lublin Voivodeship, 20-582, Poland
FutureMeds Warszawa Centrum
Warsaw, Masovian Voivodeship, 00-215, Poland
Dr Sękowska Leczenie Bólu
Warsaw, Masovian Voivodeship, 01-018, Poland
Silmedic
Katowice, Silesian Voivodeship, 40-282, Poland
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Kyǒnggi-do, 18450, South Korea
Ewha Womans University Seoul Hospital
Gangseo-gu, Seoul-teukbyeolsi [seoul], 07804, South Korea
Nowon Eulji Medical Center, Eulji University
Seoul, Seoul-teukbyeolsi [seoul], 01830, South Korea
Kangbuk Samsung Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03181, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea
Hospital Clínic de Barcelona
Barcelona, Barcelona [barcelona], 08036, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
FutureMeds Spain Cádiz
Chiclana de la Frontera, Cádiz, 11139, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital La Princesa
Madrid, 28006, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47010, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009, Spain
West Walk Surgery
Bristol, Bristol, CITY of, BS37 4AX, United Kingdom
Bioluminux
Milton Keynes, Buckinghamshire, MK15 0DU, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, EAST Yorkshire, HU3 2JZ, United Kingdom
Re:Cognition Health - London
London, England, W1G 8TA, United Kingdom
The Walton Centre NHS Foundation Trust
Fazakerley, Liverpool, L9 7LJ, United Kingdom
Panthera Clinic - York
York, North Yorkshire, YO24 4LJ, United Kingdom
Panthera Biopartners - Glasgow
Glasgow, Scotland, G51 4TY, United Kingdom
Panthera Biopartners - Sheffield
Sheffield, S2 5FX, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2024
First Posted
October 15, 2024
Study Start
March 11, 2025
Primary Completion (Estimated)
November 29, 2026
Study Completion (Estimated)
March 30, 2027
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.