A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
NCT ID: NCT06641466
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
723 participants
INTERVENTIONAL
2025-03-11
2027-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
QUADRUPLE
Study Groups
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Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing
Rimegepant
Rimegepant 75 mg ODT for 7 days
Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing
Rimegepant
Rimegepant 75 mg ODT for acute treatment as needed
Placebo
Placebo Comparator
Matching placebo oral disintegrating tablets for 7 days
Standard of Care
Standard of Care
Standard of care for acute treatment as needed
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
45 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Hope Clinical Research, Inc.
Canoga Park, California, United States
Axiom Research
Colton, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
VIN - Aventura
Aventura, Florida, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Urban Family Practice Associates
Marietta, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
St Luke's Clinic - Neurology
Meridian, Idaho, United States
Alliance for Multispecialty Research - Medisphere Medical Research Center
Evansville, Indiana, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, United States
Clinvest Headlands Llc
Springfield, Missouri, United States
St. Charles Clinical Research
Weldon Spring, Missouri, United States
McGill Family Practice
Papillion, Nebraska, United States
Excel Clinical Research, LLC
Las Vegas, Nevada, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolina Women's Research and Wellness Center
Durham, North Carolina, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, United States
Thomas Jefferson University, Jefferson Headache Center
Philadelphia, Pennsylvania, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
AMR Clinical
Knoxville, Tennessee, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
MedStar Health Neurology/MedStar Georgetown Headache Center
McLean, Virginia, United States
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires, Buenos Aires, Argentina
Mautalen Salud e Investigación
Buenos Aires, Buenos Aires F.D., Argentina
CaRe Clinic
Red Deer, Alberta, Canada
OCT Research ULC
Kelowna, British Columbia, Canada
Centre for Neurology Studies
Surrey, British Columbia, Canada
Centricity Research Halifax Multispecialty
Halifax, Nova Scotia, Canada
Aggarwal and Associates Limited
Brampton, Ontario, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, Canada
Centre de Recherche Saint-Louis inc.
Lévis, Quebec, Canada
Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Hebei General Hospital
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Shaanxi provincial people's hospital
Xi'an, Shaanxi, China
Xianyang Hospital of Yan'an University
Xianyang, Shaanxi, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Qingdao Central Hospital, University of Health and Rehabilitation Sciences
Qingdao, , China
Shanghai East Hospital
Shanghai, , China
Rigshospitalet, Glostrup
Glostrup Municipality, , Denmark
Region Midtjylland, Regionshospitalet Viborg
Viborg, , Denmark
Klinische Forschung Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, , Germany
FutureMeds GmbH
Berlin, , Germany
Neurologie Berlin
Berlin, , Germany
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Konan Medical Center
Kobe, Hyōgo, Japan
Tatsuoka Neurology Clinic
Kyoto-shi Shimogyo-ku, Kyoto, Japan
Sendai Headache and Neurology Clinic
Sendai, Miyagi, Japan
Tokyo Headache Clinic
Shibuya-ku, Tokyo, Japan
Nagaseki Headache Clinic
Kai, Yamanashi, Japan
Tanaka Neurosurgery&Headache Clinic
Kagoshima, , Japan
Tanaka Neurosurgical Clinic
Kagoshima, , Japan
Instytut Zdrowia Dr Boczarska Jedynak
Oświęcim, Lesser Poland Voivodeship, Poland
MIGRE Polskie Centrum Leczenia Migreny
Wroclaw, Lower Silesian Voivodeship, Poland
NZOZ Neuromed M.i M. Nastaj
Lublin, Lublin Voivodeship, Poland
Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej
Lublin, Lublin Voivodeship, Poland
FutureMeds Warszawa Centrum
Warsaw, Masovian Voivodeship, Poland
Dr Sękowska Leczenie Bólu
Warsaw, Masovian Voivodeship, Poland
Silmedic
Katowice, Silesian Voivodeship, Poland
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Kyǒnggi-do, South Korea
Ewha Womans University Seoul Hospital
Gangseo-gu, Seoul-teukbyeolsi [seoul], South Korea
Nowon Eulji Medical Center, Eulji University
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Kangbuk Samsung Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Hospital Clínic de Barcelona
Barcelona, Barcelona [barcelona], Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
FutureMeds Spain Cádiz
Chiclana de la Frontera, Cádiz, Spain
Hospital La Princesa
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
West Walk Surgery
Bristol, Bristol, CITY of, United Kingdom
Bioluminux
Milton Keynes, Buckinghamshire, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, EAST Yorkshire, United Kingdom
Re:Cognition Health - London
London, England, United Kingdom
Panthera Biopartners - Sheffield
Sheffield, , United Kingdom
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT06641466
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4951063
Identifier Type: -
Identifier Source: org_study_id