Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
NCT ID: NCT05217927
Last Updated: 2025-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1415 participants
INTERVENTIONAL
2022-03-04
2024-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing
Double-blind Treatment Phase: Rimegepant 75 mg ODT dosed daily
Open-Label Extension Phase:
Rimegepant 75 mg ODT dosed daily
Rimegepant 75mg daily dosing
Daily
Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosing
Double-blind Treatment Phase: Rimegepant 75 mg ODT every other day dosing alternating with matching placebo
Rimegepant 75mg every other day dosing
Every other day
Placebo comparator dosing
Double-blind Treatment Phase: matching placebo dosed daily
Placebo comparator dosing
Placebo comparator
Interventions
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Rimegepant 75mg daily dosing
Daily
Rimegepant 75mg every other day dosing
Every other day
Placebo comparator dosing
Placebo comparator
Eligibility Criteria
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Inclusion Criteria
1. Age of onset of migraines prior to 50 years of age
2. Migraine attacks, on average, lasting 4-72 hours if untreated
3. Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol
Exclusion Criteria
1. WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug
2. Women who are pregnant or breastfeeding
3. Women with a positive pregnancy test at screening or prior to study drug administration
2. Prohibited Medications:
1. Use of prophylactic migraine medication within 30 days prior to the Screening Visit.
2. History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
3. Use of medication accepted for treatment of acute migraine for a nonmigraine indication on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
4. Subjects who previously discontinued biologic migraine medication must have done so at least 6 months (24 weeks) prior to the Screening Visit.
5. Subjects taking a prohibited medication as defined per protocol
18 Years
ALL
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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AMR Clinical
Tempe, Arizona, United States
Axiom Research, Llc
Colton, California, United States
Clinical Research Institute
Los Angeles, California, United States
Wr-Pri, Llc
Newport Beach, California, United States
California Neuroscience Research Medical Group, inc.
Sherman Oaks, California, United States
Neurology Offices of South Florida, PLLC
Boca Raton, Florida, United States
AppleMed Research Group, LLC
Miami, Florida, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Collective Medical Research
Overland Park, Kansas, United States
Clinvest Research, LLC
Springfield, Missouri, United States
Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, United States
Dent Neurosciences Research Center, Inc.
Amherst, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, United States
Wellnow Urgent Care and Research
Columbus, Ohio, United States
Hometown Urgent Care and Research
Huber Heights, Ohio, United States
Velocity Clinical Research, Medford
Medford, Oregon, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, United States
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, United States
Velocity Clinical Research - Columbia
Columbia, South Carolina, United States
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, United States
Tribe Clinical Research LLC
Greenville, South Carolina, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
APD Clinical Research
Magnolia, Texas, United States
Wasatch Clinical Research , LLC(Administrative Location)
Salt Lake City, Utah, United States
Seattle Clinical Research Center
Seattle, Washington, United States
Medizinische Universitat Innsbruck
Innsbruck, Tyrol, Austria
Christian-Doppler-Klinik
Salzburg, , Austria
Calgary Headache & Assessment Management Program (CHAMP)
Calgary, Alberta, Canada
OCT Research ULC
Kelowna, British Columbia, Canada
James K. Lai MD Inc.
Vancouver, British Columbia, Canada
Centricity Research
Halifax, Nova Scotia, Canada
Aggarwal and Associates Limited
Brampton, Ontario, Canada
Manna Research Inc. (Burlington North)
Burlington, Ontario, Canada
Milestone Research Inc.
London, Ontario, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, Canada
Mirtorabi Medicine Professional Corporation
Stouffville, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Manna Research (Toronto)
Toronto, Ontario, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Hopital Gabriel Montpied
Clermont-Ferrand, , France
Hopital de La Timone
Marseille, , France
Klinische Forschung Karlsruhe GmbH
Karlsruhe, Baden-Wurttemberg, Germany
Vitos Orthopaedische Klinik Kassel
Kassel, Hesse, Germany
Siteworks - Zentrum fur klinische Studien Hannover
Hanover, Lower Saxony, Germany
Arztepartnerschaft Dr. med. J. Springub/ W. Schwarz -Studienzentrum Nord-West
Westerstede, Lower Saxony, Germany
Klinische Forschung Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, Germany
Klinische Forschung Dresden GmbH
Dresden, Saxony, Germany
Universitatsklinikum Jena
Jena, Thuringia, Germany
Studienzentrum Dr. A Schwittay
Böhlen, , Germany
Datamed GmbH
Cologne, , Germany
Kopfschmerzzentrum Frankfurt
Frankfurt, , Germany
Klinische Forschung Hamburg GmbH
Hamburg, , Germany
Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
Kiel, , Germany
Ospedale Sant Andrea - Facolta Medicina Psicologia - Universita degli Studi di Roma Sapienza
Rome, Lazio, Italy
Fondazione Mondino - Istituto Neurologico Nazionale IRCCS
Pavia, Padua, Italy
Azienda Ospedaliero Universitaria di Careggi - Cliniche Mediche
Florence, Tuscany, Italy
IRCCS Istituto delle Scienze Neurologiche Bologna, Unità Operativa di Neurologia - Ospedale Bellaria
Bologna, , Italy
ASST Spedali Civili di Brescia, U.O. Neurologia
Brescia, , Italy
Neurorehabilitation Unit-ICOT Istituto Marco Pasquali
Latina, , Italy
Istituto Neurologico "Carlo Besta" Fondazione IRCCS
Milan, , Italy
IRCCS San Raffaele Roma
Rome, , Italy
Solumed Centrum Medyczne
Poznan, Greater Poland Voivodeship, Poland
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, Poland
Krakowska Akademia Neurologii Sp. Z o.o.
Krakow, Lesser Poland Voivodeship, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, Lower Silesian Voivodeship, Poland
Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej
Lublin, Lublin Voivodeship, Poland
Next Stage Sp. Z o.o.
Warsaw, Masovian Voivodeship, Poland
Wojskowy Instytut Medyczny
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Pratia Czestochowa
Częstochowa, Silesian Voivodeship, Poland
Centrum Medyczne Pratia Katowice
Katowice, Silesian Voivodeship, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
Katowice, Silesian Voivodeship, Poland
Neurologia Slaska Centrum Medyczne
Katowice, Silesian Voivodeship, Poland
NZOZ Neuromed M. i M. Nastaj Sp. P.
Lublin, , Poland
MTZ Clinical Research Powered by Pratia
Warsaw, , Poland
Neurology Service: Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Clinico Universitario de Valladolid • HCUV
Valladolid, Castille and León, Spain
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Instituto de Investigaciones del Sueno
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Virgen del Rocio Hospital
Seville, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Pharmasite
Malmo, Skåne County, Sweden
CTC Clinical Trial Consultants AB
Stockholm, Stockholms LÄN [se-01], Sweden
Ladulaas Clinical Trials
Borås, , Sweden
ProbarE i Lund
Lund, , Sweden
ProbarE i Stockholm AB
Stockholm, , Sweden
Studieenheten Akademiskt Specialistcentrum SLSO
Stockholm, , Sweden
Royal Primary Care Ashgate, Chesterfield Royal Hospital, NHS Foundation Trust
Chesterfield, Derbyshire, United Kingdom
Panthera Biopartners
Rochdale, Great Manchester, United Kingdom
Re:Cognition Health - Winchester
Winchester, Hampshire, United Kingdom
Panthera Bio Partners
Preston, Lancashire, United Kingdom
Re:Cognition Health - London
London, Marylebone, United Kingdom
Re:Cognition Health-Private Practice
London, Marylebone, United Kingdom
Lakeside Healthcare Research
Corby, Northamptonshire, United Kingdom
CPS Research
Glasgow, Scotland, United Kingdom
Re-Cognition Health - Bristol
Bristol, South WEST, United Kingdom
Panthera Biopartners - Sheffield
Sheffield, South Yorkshire, United Kingdom
Re-Cognition Health
Guildford, Surrey, United Kingdom
Re-Cognition Health
Birmingham, WEST Midlands, United Kingdom
Panthera Biopartners Glasgow
Glasgow, , United Kingdom
Panthera Biopartners - Enfield
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2021-005239-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C4951010
Identifier Type: OTHER
Identifier Source: secondary_id
BHV3000-404
Identifier Type: -
Identifier Source: org_study_id