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

Last updated: January 30, 2025
Sponsor: Pfizer
Overall Status: Completed

Phase

4

Condition

Pain

Oral Facial Pain

Chronic Pain

Treatment

Rimegepant 75mg daily dosing

Rimegepant 75mg every other day dosing

Placebo comparator dosing

Clinical Study ID

NCT05217927
BHV3000-404
2021-005239-22
C4951010
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Target Population: Subject has at least 1 year history of episodic migraine (with orwithout aura) consistent with a diagnosis according to the InternationalClassification 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 priorto the Screening Visit (month is defined as 4 weeks for the purpose of this protocol

Exclusion

Exclusion Criteria:

  1. Sex and Reproductive Status:

  2. WOCBP who are unwilling or unable to use an acceptable contraceptive method orabstinence to avoid pregnancy for the entire study and for 60 days after thelast dose of study drug

  3. Women who are pregnant or breastfeeding

  4. Women with a positive pregnancy test at screening or prior to study drugadministration

  5. Prohibited Medications:

  6. Use of prophylactic migraine medication within 30 days prior to the ScreeningVisit.

  7. History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) on ≥ 15 days per month during the 3 months (12weeks) prior to the Screening Visit.

  8. Use of medication accepted for treatment of acute migraine for a nonmigraineindication on ≥ 15 days per month during the 3 months (12 weeks) prior to theScreening Visit.

  9. Subjects who previously discontinued biologic migraine medication must havedone so at least 6 months (24 weeks) prior to the Screening Visit.

  10. Subjects taking a prohibited medication as defined per protocol

Study Design

Total Participants: 698
Treatment Group(s): 3
Primary Treatment: Rimegepant 75mg daily dosing
Phase: 4
Study Start date:
March 04, 2022
Estimated Completion Date:
December 11, 2024

Connect with a study center

  • Medizinische Universitat Innsbruck

    Innsbruck, Tirol 6020
    Austria

    Site Not Available

  • Medizinische Universität Innsbruck - Universitätsklinik für Neurologie

    Innsbruck, 06020
    Austria

    Site Not Available

  • Christian-Doppler-Klinik

    Salzburg, 5020
    Austria

    Site Not Available

  • Paracelsus Medizinischen Privatuniversitaet - Christian-Doppler-Klinik (CDK)

    Salzburg, 5020
    Austria

    Site Not Available

  • Calgary Headache & Assessment Management Program (CHAMP)

    Calgary, Alberta T3M 1M4
    Canada

    Site Not Available

  • Calgary Headache Assessment and Management Program (CHAMP)

    Calgary, Alberta T3M1M4
    Canada

    Site Not Available

  • OCT Research ULC

    Kelowna, British Columbia V1Y 1Z9
    Canada

    Site Not Available

  • James K. Lai MD Inc.

    Vancouver, British Columbia V5Z 1K3
    Canada

    Site Not Available

  • Centricity Research

    Halifax, Nova Scotia B3S 1N2
    Canada

    Site Not Available

  • True North Clinical Research Inc.

    Halifax, Nova Scotia B3S 1N2
    Canada

    Site Not Available

  • Aggarwal and Associates Limited

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • Manna Research Inc. (Burlington North)

    Burlington, Ontario L7M 4Y1
    Canada

    Site Not Available

  • Milestone Research Inc.

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Mirtorabi Medicine Professional Corporation

    Stouffville, Ontario L4A 1H2
    Canada

    Site Not Available

  • Manna Research (Toronto)

    Toronto, Ontario M9W 4L6
    Canada

    Site Not Available

  • Toronto Memory Program

    Toronto, Ontario M3B 2S7
    Canada

    Site Not Available

  • Diex Recherche Sherbrooke Inc.

    Sherbrooke, Quebec J1L 0H8
    Canada

    Site Not Available

  • Centre Hospitalier Annecy Genevois

    Metz-Tessy, Pringy Cedex 74374
    France

    Site Not Available

  • CHU Clermont-Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, 63003
    France

    Site Not Available

  • Hopital Gabriel Montpied

    Clermont-Ferrand cedex, 63003
    France

    Site Not Available

  • Hôpital Roger Salengro CHU Lille

    Lille, 59037
    France

    Site Not Available

  • Hopital Roger Salengro CHU Lille

    Lille Cedex, 59037
    France

    Site Not Available

  • Hopital de La Timone

    Marseille, 13385
    France

    Site Not Available

  • Centre Hospitalier Annecy Genevois

    Pringy Cedex, 74374
    France

    Site Not Available

  • Klinische Forschung Karlsruhe GmbH

    Karlsruhe, Baden-württemberg 76137
    Germany

    Site Not Available

  • Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik

    Muenchen, Bavaria 81377
    Germany

    Site Not Available

  • Vitos Orthopaedische Klinik Kassel

    Kassel, Hessen 34131
    Germany

    Site Not Available

  • Arztepartnerschaft Dr. med. J. Springub/ W. Schwarz -Studienzentrum Nord-West

    Westerstede, Lower Saxony 26655
    Germany

    Site Not Available

  • Siteworks - Zentrum fur klinische Studien Hannover

    Hanover, Lower-saxony 30449
    Germany

    Site Not Available

  • Klinische Forschung Schwerin GmbH

    Schwerin, Mecklenburg-vorpommern 19055
    Germany

    Site Not Available

  • Klinische Forschung Dresden GmbH

    Dresden, Saxony 01069
    Germany

    Site Not Available

  • Universitatsklinikum Jena

    Jena, Thuringia 07747
    Germany

    Site Not Available

  • Klinische Forschung Berlin-Mitte

    Berlin, 10117
    Germany

    Site Not Available

  • Neurologisches Facharztzentrum Berlin (NFZB) - Sankt Gertrauden-Krankenhaus Location

    Berlin, 10713
    Germany

    Site Not Available

  • Studienzentrum Dr. A Schwittay

    Böhlen, 04564
    Germany

    Site Not Available

  • Universitaetsklinikum Essen - Klinik und Poliklinik fuer Neurologie - Schwindel-Zentrum Essen

    Essen, 45147
    Germany

    Site Not Available

  • Kopfschmerzzentrum Frankfurt

    Frankfurt, 65929
    Germany

    Site Not Available

  • Klinische Forschung Hamburg GmbH

    Hamburg, 20253
    Germany

    Site Not Available

  • Zentrum für klinische Studien Hannover

    Hannover, 30449
    Germany

    Site Not Available

  • Neurologisch-verhaltensmedizinische Schmerzklinik Kiel

    Kiel, 24194
    Germany

    Site Not Available

  • Datamed GmbH

    Koeln, 50935
    Germany

    Site Not Available

  • NeuroMed Campus - Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus

    Koln, 50935
    Germany

    Site Not Available

  • Ludwig-Maximilians-Universitaet Muenchen Klinikum der Universitaet Muenchen - Campus Grosshadern

    Munich, 81377
    Germany

    Site Not Available

  • Fachuebergreifende Gemeinschaftspraxis Dr.Med. Joachim Springub & Wolfgang Schwarz

    Westerstede, no info
    Germany

    Site Not Available

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

    Napoli, Campania 80138
    Italy

    Site Not Available

  • AOU Careggi - Centro Cefalee

    Firenze, Florence 50134
    Italy

    Site Not Available

  • Centro per la Diagnosi e Terapia delle Cefalee Azienda Ospedaliero-Universitaria di Trieste

    Trieste, Friuli-venezia Giulia 34149
    Italy

    Site Not Available

  • Ospedale Sant Andrea - Facolta Medicina Psicologia - Universita degli Studi di Roma Sapienza

    Roma, Lazio 00189
    Italy

    Site Not Available

  • Fondazione Mondino - Istituto Neurologico Nazionale IRCCS

    Pavia, Padua 27100
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria di Careggi - Cliniche Mediche

    Florence, Tuscany 50134
    Italy

    Site Not Available

  • Azienda Ospedaliera San Giuseppe Moscati-Unita di Neurologia

    Avellino, 83100
    Italy

    Site Not Available

  • IRCCS Istituto delle Scienze Neurologiche Bologna

    Bologna, 40139
    Italy

    Site Not Available

  • IRCCS Istituto delle Scienze Neurologiche Bologna, Unità Operativa di Neurologia - Ospedale Bellaria

    Bologna, 40139
    Italy

    Site Not Available

  • ASST Spedali Civili di Brescia, U.O. Neurologia

    Brescia, 25123
    Italy

    Site Not Available

  • Neurorehabilitation Unit-ICOT Istituto Marco Pasquali

    Latina, 04100
    Italy

    Site Not Available

  • Istituto Neurologico "Carlo Besta" Fondazione IRCCS

    Milan, 20133
    Italy

    Site Not Available

  • Azienda Ospedaliera Sant'Andrea, UOC Neurologia

    Rome, 00195
    Italy

    Site Not Available

  • IRCCS San Raffaele Roma

    Rome, 00197
    Italy

    Site Not Available

  • Ospedale di Cattinara, Centro per la Diagnosi e Terapia delle Cefalee

    Trieste, 34149
    Italy

    Site Not Available

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, Dolnoslaskie 52-210
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, Kujawsko-pomorskie 85-796
    Poland

    Site Not Available

  • Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej

    Lublin, Lubelskie 20-582
    Poland

    Site Not Available

  • Krakowska Akademia Neurologii Sp. Z o.o.

    Krakow, Malopolskie 31-505
    Poland

    Site Not Available

  • Krakowska Akademia Neurologil Sp. Z o.o.

    Krakow, Malopolskie 31-505
    Poland

    Site Not Available

  • Next Stage Sp. Z o.o.

    Warszawa, Mazowieckie 02-121
    Poland

    Site Not Available

  • Wojskowy Instytut Medyczny

    Warszawa, Mazowieckie 04-141
    Poland

    Site Not Available

  • Pratia MCM Krakow

    Krakow, Małopolskie 30-510
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Czestochowa

    Czestochowa, Slaskie 42-200
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Katowice

    Katowice, Slaskie 40-081
    Poland

    Site Not Available

  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

    Katowice, Slaskie 40-123
    Poland

    Site Not Available

  • Neurologia Slaska Centrum Medyczne

    Katowice, Slaskie 40-689
    Poland

    Site Not Available

  • Solumed Centrum Medyczne

    Poznan, Wielkopolskie 60-529
    Poland

    Site Not Available

  • NZOZ Neuromed M. i M. Nastaj Sp. P.

    Lublin, 20-064
    Poland

    Site Not Available

  • MTZ Clinical Research Powered by Pratia

    Warszawa, 02-172
    Poland

    Site Not Available

  • Neurology Service: Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valladolid • HCUV

    Valladolid, Castilla Y LEON 47003
    Spain

    Site Not Available

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra 36312
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Instituto de Investigaciones del Sueno

    Madrid, 28036
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Virgen del Rocio Hospital

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe - Department of Neurology

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47005
    Spain

    Site Not Available

  • Ladulaas Clinical Trials

    Boras, SE 506 30
    Sweden

    Site Not Available

  • Pharmasite

    Malmö, Skåne 21152
    Sweden

    Site Not Available

  • CTC Clinical Trial Consultants AB

    Stockholm, Stockholms LÄN [se-01] 171 64
    Sweden

    Site Not Available

  • Ladulaas Clinical Trials

    Boraas, SE 506 30
    Sweden

    Site Not Available

  • ProbarE i Lund

    Lund, 222 22
    Sweden

    Site Not Available

  • ProbarE i Stockholm AB

    Stockholm, 113 29
    Sweden

    Site Not Available

  • Studieenheten Akademiskt Specialistcentrum SLSO

    Stockholm, 11361
    Sweden

    Site Not Available

  • Royal Primary Care Ashgate, Chesterfield Royal Hospital, NHS Foundation Trust

    Chesterfield, Derbyshire S40 4AA
    United Kingdom

    Site Not Available

  • Panthera Biopartners

    Rochdale, Great Manchester O11 4AU
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Winchester

    Winchester, Hampshire SO21 1HU
    United Kingdom

    Site Not Available

  • Intelligent Clinical

    Glasgow, Lanarkshire G20 0XA
    United Kingdom

    Site Not Available

  • Panthera Bio Partners

    Preston, Lancashire PR2 9QB
    United Kingdom

    Site Not Available

  • Re:Cognition Health - London

    London, Marylebone W1G 9JF
    United Kingdom

    Site Not Available

  • Re:Cognition Health-Private Practice

    London, Marylebone W1G9RU
    United Kingdom

    Site Not Available

  • Lakeside Healthcare Research

    Corby, Northamptonshire NN17 2UR
    United Kingdom

    Site Not Available

  • CPS Research

    Glasgow, Scotland G20 7BE
    United Kingdom

    Site Not Available

  • Re-Cognition Health - Bristol

    Bristol, South WEST BS32 4SY
    United Kingdom

    Site Not Available

  • Panthera Biopartners - Sheffield

    Sheffield, South Yorkshire S2 5FX
    United Kingdom

    Site Not Available

  • Re-Cognition Health

    Guildford, Surrey GU2 7YD
    United Kingdom

    Site Not Available

  • Re-Cognition Health

    Birmingham, WEST Midlands B16 8LT
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Birmingham

    Birmingham, B16 8LT
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Bristol

    Bristol, BS32 4SY
    United Kingdom

    Site Not Available

  • Panthera Biopartners Enfield

    Enfield, EN3 4GS
    United Kingdom

    Site Not Available

  • Panthera Biopartners Glasgow

    Glasgow, G51 4TY
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Guildford

    Guildford, GU2 7YD
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Panthera Biopartners - Enfield

    London, EN3 4GS
    United Kingdom

    Site Not Available

  • Re:Cognition Health Limited

    London, W1G 9JF
    United Kingdom

    Site Not Available

  • Cognition Health - Winchester

    Winchester, SO21 1HU
    United Kingdom

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Tempe, Arizona 85281
    United States

    Site Not Available

  • Axiom Research, Llc

    Colton, California 92324
    United States

    Site Not Available

  • Clinical Research Institute

    Los Angeles, California 90048
    United States

    Site Not Available

  • Wr-Pri, Llc

    Newport Beach, California 92660
    United States

    Site Not Available

  • California Neuroscience Research Medical Group, inc.

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Neurology Offices of South Florida, PLLC

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • AppleMed Research Group, LLC

    Miami, Florida 33126
    United States

    Site Not Available

  • Clinical Investigation Specialists, Inc.

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Collective Medical Research

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Collective Medical Research

    Prairie Village, Kansas 66208
    United States

    Site Not Available

  • Clinvest Research, LLC

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Dent Neurosciences Research Center, Inc.

    Amherst, New York 14226
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • Upstate Clinical Research Associates, LLC

    Williamsville, New York 14221
    United States

    Site Not Available

  • Wellnow Urgent Care and Research

    Columbus, Ohio 43228
    United States

    Site Not Available

  • WellNow Urgent Care and Research

    Dayton, Ohio 45424
    United States

    Site Not Available

  • WellNow Urgent Care and Research

    Huber Heights, Ohio 45424
    United States

    Site Not Available

  • Wellnow Urgent Care and Research

    Troy, Ohio 45373
    United States

    Site Not Available

  • Velocity Clinical Research, Medford

    Medford, Oregon 97504
    United States

    Site Not Available

  • Preferred Primary Care Physicians, Inc.

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Velocity Providence

    East Greenwich, Rhode Island 28180
    United States

    Site Not Available

  • Velocity Clinical Research - Columbia

    Columbia, South Carolina 29204
    United States

    Site Not Available

  • Velocity Clinical Research, Gaffney

    Gaffney, South Carolina 29340
    United States

    Site Not Available

  • Velocity Clinical Research-Gaffney

    Gaffney, South Carolina 29340
    United States

    Site Not Available

  • Tribe Clinical Research LLC

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Clinical Research Associates, Inc.

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Site Not Available

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas 75231
    United States

    Site Not Available

  • Texas Center for Drug Development, Inc.

    Houston, Texas 77081
    United States

    Site Not Available

  • APD Clinical Research

    Magnolia, Texas 77355
    United States

    Site Not Available

  • Wasatch Clinical Research , LLC(Administrative Location)

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Seattle Clinical Research Center

    Seattle, Washington 98105
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.