Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

Phase 4

Active, not recruiting

• Conditions: Migraine
• Interventions: Drug: Rimegepant 75mg daily dosing; Drug: Rimegepant 75mg every other day dosing; Drug: Placebo comparator dosing

• Registration Number: NCT05217927
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-01
• Study Start: 2022-03-04
• Primary Completion: 2024-10-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Study Completion: 2024-12-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 698

Inclusion Criteria

1. Target Population: Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:

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

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Exclusion Criteria

1. Sex and Reproductive Status:

   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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing	Rimegepant 75mg daily dosing	Double-blind Treatment Phase: Rimegepant 75 mg ODT dosed daily Open-Label Extension Phase: Rimegepant 75 mg ODT dosed daily
Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosing	Rimegepant 75mg every other day dosing	Double-blind Treatment Phase: Rimegepant 75 mg ODT every other day dosing alternating with matching placebo
Placebo comparator dosing	Placebo comparator dosing	Double-blind Treatment Phase: matching placebo dosed daily

Primary Outcome Measures

Name	Time	Method
Mean change from the Observation Phase in the number of migraine days per month over the entire Double-blind Treatment Phase (Weeks 1-12)	3 months (12 weeks)	Change from baseline in mean number of migraine days per month

Secondary Outcome Measures

Name	Time	Method
Mean change from the Observation Phase	Weeks 1 to 4	number of migraine days per month in the first 4 weeks of the Double-blind Treatment Phase.
Number and percentage of subjects treated with rimegepant with AST or ALT elevations.	24 Weeks	\>3x ULN concurrent (i.e., on the same laboratory collection date) with total bilirubin \> 2x ULN during the Double-blind Treatment and Open-label Extension Phases.
Mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) restrictive role function.	At Week 12	Domain score of the Double-blind Treatment Phase.
Number and percentage of subjects with AEs by intensity.	24 Weeks	Serious adverse events (SAEs), AEs leading to study drug discontinuation, and grade 3 to 4 laboratory test abnormalities during the Double-blind Treatment and Open-label Extension Phases.
Proportion of subjects with > 50% reduction from the Observation Phase (Weeks 1 to 12).	3 months (12 weeks)	Number of moderate to severe migraine days per month over the entire Double-blind Treatment Phase
Mean change from the Observation Phase.	Weeks 9 to 12	Number of migraine days per month in the last 4 weeks of the Double-blind Treatment Phase.
Number and percentage of subjects treated with rimegepant with hepatic-related AEs	24 Weeks	By intensity and hepatic-related AEs leading to study drug discontinuation during the Double-blind Treatment and Open-label Extension Phases.
Mean number of acute migraine-specific medication days per month.	Weeks 1 to 12	Over the entire Double-blind Treatment Phase. Acute migraine-specific medications are triptans and ergotamine.

Trial Locations

Locations (127)

Alliance for Multispecialty Research, LLC; 🇺🇸 Las Vegas, Nevada, 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; 🇺🇸 Prairie Village, Kansas, United States

Clinvest Research, LLC; 🇺🇸 Springfield, Missouri, United States

Preferred Primary Care Physicians, Inc.; 🇺🇸 Pittsburgh, Pennsylvania, United States

Dent Neurosciences Research Center, Inc.; 🇺🇸 Amherst, New York, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Upstate Clinical Research Associates, LLC; 🇺🇸 Williamsville, New York, United States

Wellnow Urgent Care and Research; 🇺🇸 Troy, Ohio, United States

WellNow Urgent Care and Research; 🇺🇸 Huber Heights, Ohio, United States

Velocity Clinical Research, Medford; 🇺🇸 Medford, Oregon, 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, Tirol, Austria

Christian-Doppler-Klinik; 🇦🇹 Salzburg, Austria

Paracelsus Medizinischen Privatuniversitaet - Christian-Doppler-Klinik (CDK); 🇦🇹 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

True North Clinical Research Inc.; 🇨🇦 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 cedex, France

Hopital Roger Salengro CHU Lille; 🇫🇷 Lille Cedex, France

Hopital de La Timone; 🇫🇷 Marseille, France

Centre Hospitalier Annecy Genevois; 🇫🇷 Pringy Cedex, France

Klinische Forschung Karlsruhe GmbH; 🇩🇪 Karlsruhe, Germany

Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik; 🇩🇪 Muenchen, Bavaria, Germany

Vitos Orthopaedische Klinik Kassel; 🇩🇪 Kassel, Hessen, Germany

Arztepartnerschaft Dr. med. J. Springub/ W. Schwarz -Studienzentrum Nord-West; 🇩🇪 Westerstede, Lower Saxony, Germany

Siteworks - Zentrum fur klinische Studien Hannover; 🇩🇪 Hanover, Lower-saxony, Germany

Klinische Forschung Schwerin GmbH; 🇩🇪 Schwerin, Germany

Klinische Forschung Dresden GmbH; 🇩🇪 Dresden, Germany

Universitatsklinikum Jena; 🇩🇪 Jena, Thuringia, Germany

Klinische Forschung Berlin-Mitte; 🇩🇪 Berlin, Germany

Neurologisches Facharztzentrum Berlin (NFZB) - Sankt Gertrauden-Krankenhaus Location; 🇩🇪 Berlin, Germany

Studienzentrum Dr. A Schwittay; 🇩🇪 Böhlen, Germany

Universitaetsklinikum Essen - Klinik und Poliklinik fuer Neurologie - Schwindel-Zentrum Essen; 🇩🇪 Essen, Germany

Kopfschmerzzentrum Frankfurt; 🇩🇪 Frankfurt, Germany

Klinische Forschung Hamburg GmbH; 🇩🇪 Hamburg, Germany

Zentrum für klinische Studien Hannover; 🇩🇪 Hannover, Germany

Neurologisch-verhaltensmedizinische Schmerzklinik Kiel; 🇩🇪 Kiel, Germany

Datamed GmbH; 🇩🇪 Koeln, Germany

NeuroMed Campus - Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus; 🇩🇪 Koln, Germany

Ludwig-Maximilians-Universitaet Muenchen Klinikum der Universitaet Muenchen - Campus Grosshadern; 🇩🇪 Munich, Germany

Fachuebergreifende Gemeinschaftspraxis Dr.Med. Joachim Springub & Wolfgang Schwarz; 🇩🇪 Westerstede, Germany

Azienda Ospedaliera Universitaria Luigi Vanvitelli; 🇮🇹 Napoli, Campania, Italy

AOU Careggi - Centro Cefalee; 🇮🇹 Firenze, Florence, Italy

Centro per la Diagnosi e Terapia delle Cefalee Azienda Ospedaliero-Universitaria di Trieste; 🇮🇹 Trieste, Friuli-venezia Giulia, Italy

Ospedale Sant Andrea - Facolta Medicina Psicologia - Universita degli Studi di Roma Sapienza; 🇮🇹 Roma, Lazio, Italy

Fondazione Mondino - Istituto Neurologico Nazionale IRCCS; 🇮🇹 Pavia, Padua, Italy

Azienda Ospedaliero Universitaria di Careggi - Cliniche Mediche; 🇮🇹 Florence, Tuscany, Italy

Azienda Ospedaliera San Giuseppe Moscati-Unita di Neurologia; 🇮🇹 Avellino, 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

Azienda Ospedaliera Sant'Andrea, UOC Neurologia; 🇮🇹 Rome, Italy

IRCCS San Raffaele Roma; 🇮🇹 Rome, Italy

Ospedale di Cattinara, Centro per la Diagnosi e Terapia delle Cefalee; 🇮🇹 Trieste, Italy

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak; 🇵🇱 Wroclaw, Dolnoslaskie, Poland

Centrum Medyczne Pratia Bydgoszcz; 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej; 🇵🇱 Lublin, Lubelskie, Poland

Krakowska Akademia Neurologii Sp. Z o.o.; 🇵🇱 Krakow, Malopolskie, Poland

Krakowska Akademia Neurologil Sp. Z o.o.; 🇵🇱 Krakow, Malopolskie, Poland

Next Stage Sp. Z o.o.; 🇵🇱 Warszawa, Mazowieckie, Poland

Wojskowy Instytut Medyczny; 🇵🇱 Warszawa, Mazowieckie, Poland

Pratia MCM Krakow; 🇵🇱 Krakow, Małopolskie, Poland

Centrum Medyczne Pratia Czestochowa; 🇵🇱 Czestochowa, Slaskie, Poland

Centrum Medyczne Pratia Katowice; 🇵🇱 Katowice, Slaskie, Poland

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS; 🇵🇱 Katowice, Slaskie, Poland

Neurologia Slaska Centrum Medyczne; 🇵🇱 Katowice, Slaskie, Poland

Solumed Centrum Medyczne; 🇵🇱 Poznan, Wielkopolskie, Poland

NZOZ Neuromed M. i M. Nastaj Sp. P.; 🇵🇱 Lublin, Poland

MTZ Clinical Research Powered by Pratia; 🇵🇱 Warszawa, Poland

Neurology Service: Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Clinico Universitario de Valladolid • HCUV; 🇪🇸 Valladolid, Castilla Y LEON, Spain

Hospital Alvaro Cunqueiro; 🇪🇸 Vigo, Pontevedra, Spain

Instituto de Investigaciones del Sueno; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Virgen del Rocio Hospital; 🇪🇸 Sevilla, Spain

Hospital Universitario y Politecnico La Fe; 🇪🇸 Valencia, Spain

Ladulaas Clinical Trials; 🇸🇪 Boraas, Sweden

Pharmasite; 🇸🇪 Malmö, Sweden

CTC Clinical Trial Consultants AB; 🇸🇪 Stockholm, Stockholms LÄN [se-01], 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

Intelligent Clinical; 🇬🇧 Glasgow, Lanarkshire, 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; 🇬🇧 Birmingham, WEST Midlands, United Kingdom

Panthera Biopartners Glasgow; 🇬🇧 Glasgow, United Kingdom

Panthera Biopartners - Enfield; 🇬🇧 London, United Kingdom

Kings College Hospital; 🇬🇧 London, United Kingdom

Re:Cognition Health Limited; 🇬🇧 London, United Kingdom