Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications

Last updated: November 19, 2024
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

4

Condition

Headaches

Chronic Pain

Pain (Pediatric)

Treatment

Rimegepant

Placebo

Clinical Study ID

NCT05518123
BHV3000-407
C4951012
2022-001176-34
2024-513270-21-00
BHV3000-407
  • Ages > 18
  • All Genders

Study Summary

This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Migraine attacks present for more than 1 year with the age of onset prior to 50years of age.

  2. Migraine attacks, on average, lasting about 4 - 72 hours, if untreated.

  3. 4 to 14 migraine days per month, on average, across the 3 months prior to theScreening Visit (month is defined as 28-days for the purpose of this protocol).

  4. Less than15 headache days (migraine or non-migraine) per month in each of the 3-months prior to the Screening Visit and throughout the Screening Phase.

  5. Subjects must be able to distinguish migraine attacks from tension/clusterheadaches. Prior inadequate response, within 10 years of the Screening Visit, toagents across 2-4 categories of recognized, orally-administered, migraine-preventivemedications where at least one example of prior inadequate response is due to lackof efficacy or prior intolerance (not contraindication).

Exclusion

Exclusion Criteria:

  1. History of cluster headaches, basilar migraine (migraine with brainstem aura), orhemiplegic migraine.

  2. Current medication overuse headaches.

  3. 15 or more headache days (migraine or non-migraine) per month in any of the 3-monthsprior to the Screening Visit or during the first 28- days of the Observation Phase.

  4. Inadequate response (due to lack of efficacy, prior intolerance, orcontraindication) to agents across > 4 categories of recognized, orallyadministered, migraine-preventive medications.

  5. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complexregional pain syndrome [CRPS]).

  6. Other pain syndromes (including trigeminal neuralgia), dementia, or significantneurological disorders (other than migraine) that, in the Investigator's opinion,interfere with study assessments of safety or efficacy.

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Rimegepant
Phase: 4
Study Start date:
November 07, 2022
Estimated Completion Date:
August 07, 2025

Connect with a study center

  • Genesis Research Services

    Broadmeadow, New South Wales 2292
    Australia

    Site Not Available

  • Genesis Research Services

    Newcastle, New South Wales 2292
    Australia

    Site Not Available

  • USC Clinical Trials Sunshine Coast

    Sippy Downs, Queensland 4556
    Australia

    Active - Recruiting

  • CerCare SA

    Wayville, South Australia 5034
    Australia

    Site Not Available

  • PainMedSA & CerCare Pty Ltd

    Wayville, South Australia 5034
    Australia

    Site Not Available

  • Medical University Innsbruck

    Innsbruck, Tirol 6020
    Austria

    Active - Recruiting

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt am Wörthersee, 9020
    Austria

    Active - Recruiting

  • Medical University of Vienna

    Vienna, A-1090
    Austria

    Site Not Available

  • UZ Brussel

    Jette, Brussels 1090
    Belgium

    Active - Recruiting

  • GZA Ziekenhuizen

    Antwerpen, 2610
    Belgium

    Active - Recruiting

  • AZ Sint-Jan

    Brugge, 8000
    Belgium

    Site Not Available

  • AZ Sint-Jan Brugge-Oostende AV

    Brugge, 8000
    Belgium

    Active - Recruiting

  • UZ Brussel

    Brussel, 1090
    Belgium

    Site Not Available

  • Jessa Ziekenhuis

    Hasselt, 3500
    Belgium

    Active - Recruiting

  • Clinique de la Citadelle

    Liège, 4000
    Belgium

    Active - Recruiting

  • Cabinet Privé Dr. Simona Sava

    Saint Nicolas Province De Liège, 4420
    Belgium

    Active - Recruiting

  • Aggarwal and Associates Limited

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • NeuPath Centre for Pain and Spine

    Brampton, Ontario L6V 1C2
    Canada

    Active - Recruiting

  • Centre de Recherche Saint-Louis/Clinique Neuro-Levis

    Levis, Quebec G6W0M5
    Canada

    Active - Recruiting

  • Clinique Neuro-Lévis

    Levis, Quebec G6W 0M5
    Canada

    Site Not Available

  • Diex Recherche Sherbrooke Inc.

    Sherbrooke, Quebec J1L 0H8
    Canada

    Site Not Available

  • ALPHA Recherche Clinique

    Quebec, G3K 2P8
    Canada

    Active - Recruiting

  • Bispebjerg Hospital

    Copenhagen NV, Capital Region 2400
    Denmark

    Active - Recruiting

  • Danish Headache Center

    Glostrup, Region Hovedstaden 2600
    Denmark

    Active - Recruiting

  • Bispebjerg Hospital

    Copenhagen, 2400
    Denmark

    Site Not Available

  • University Hospital of Southern Denmark

    Esbjerg, DK-6700
    Denmark

    Site Not Available

  • Hospitalsenhed Midt

    Viborg, DK-8800
    Denmark

    Active - Recruiting

  • Terveystalo Oy

    Helsinki, 00100
    Finland

    Site Not Available

  • Terveystalo Ruoholahti

    Helsinki, 00180
    Finland

    Active - Recruiting

  • Terveystalo Tampere

    Tampere, 33100
    Finland

    Active - Recruiting

  • Terveystalo Pulssi

    Turku, 20100
    Finland

    Active - Recruiting

  • Schmerz- und Palliativzentrum Göppingen

    Göppingen, Baden-wuerttemberg 73033
    Germany

    Active - Recruiting

  • Zentrum für klinische Forschung

    Bad Homburg, Hessen 61348
    Germany

    Active - Recruiting

  • Kopfschmerzzentrum Frankfurt

    Frankfurt, Hessen 65929
    Germany

    Active - Recruiting

  • Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre

    Frankfurt am Main, Hessen 60313
    Germany

    Active - Recruiting

  • Intermed GmbH

    Wiesbaden, Hessen 65189
    Germany

    Active - Recruiting

  • Universitätsmedizin Greifswald

    Greifswald, Mecklenburg-vorpommern 17475
    Germany

    Site Not Available

  • Synexus - Prüfzentrum Leipzig

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • Zentrum für klinische Forschung

    Bad Homburg Hessen, 61348
    Germany

    Site Not Available

  • Neurozentrum Tempelhof Berlin

    Berlin, 10827
    Germany

    Site Not Available

  • Synexus - Prüfzentrum Berlin

    Berlin, 12672
    Germany

    Terminated

  • Studiumzentrum Dr. A. Schwittay

    Böhlen Sachsen, 04564
    Germany

    Site Not Available

  • Neuropoint GmbH

    Ulm Baden-Wuerttemberg, 89073
    Germany

    Active - Recruiting

  • Studienzentrum Nordwest

    Westerstede, 26655
    Germany

    Site Not Available

  • Intermed GmbH

    Wiesbaden Hessen, 65189
    Germany

    Site Not Available

  • IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino

    Pavia, Lombardia 27100
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milano, MI 20132
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milano, MI 20132
    Italy

    Site Not Available

  • AOU Policlinico di Modena

    Modena, Emilia-Romagna, Modena 41124
    Italy

    Site Not Available

  • AOU Luigi Vanvitelli

    Napoli, Naples 80138
    Italy

    Active - Recruiting

  • Clinical Trial Center IRCCS Mondino

    Pavia (PV), Pavia 27100
    Italy

    Active - Recruiting

  • Policlinico di Bari Giovanni XXIII

    Bari, Puglia 70124
    Italy

    Site Not Available

  • Fondazione Policlinico Campus BioMedico

    Rome, RM 00128
    Italy

    Site Not Available

  • IRCCS San Raffaele

    Rome, Rome/lazio 00163
    Italy

    Active - Recruiting

  • Policlinico Universitario di Bari

    Bari, 1-70124
    Italy

    Site Not Available

  • SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi

    Florence, 50134
    Italy

    Active - Recruiting

  • IRCCS Fondazione Besta

    Milan, 20133
    Italy

    Active - Recruiting

  • University Modena e Reggio Emilia

    Modena, 41121
    Italy

    Site Not Available

  • Fondazione Mondino - Istituto Neurologico Nazionale IRCCS

    Pavia, 27100
    Italy

    Active - Recruiting

  • IRCCS Fondazione Istituto Neurologico C. Mondino

    Pavia, 27100
    Italy

    Active - Recruiting

  • IRCCS San Raffaele Roma

    Rome, 00197
    Italy

    Active - Recruiting

  • Unidad de Investigación En Salud de Chihuahua Sc

    Alcadia Tlalpan, Ciudad DE Mexico C.P. 14050
    Mexico

    Active - Recruiting

  • Phylasis Clinicas Research S. de R.L. de C.V.

    Cuautitlan Izcalli, Estado DE Mexico 54769
    Mexico

    Active - Recruiting

  • Clinical Research Institute S.C.

    Tlalnepantla de Baz, Estado DE Mexico C.P. 54055
    Mexico

    Active - Recruiting

  • Medical Care and Research S.A. de C.V.

    Merida, Yucatan 97070
    Mexico

    Site Not Available

  • Centro de Investigación Médica de Aguascalientes (CIMA)

    Aguascalientes, 20116
    Mexico

    Active - Recruiting

  • Clinstile, SA de CV

    Mexico City, CDMX 06700
    Mexico

    Active - Recruiting

  • Unidad de Investigación En Salud de Chihuahua Sc

    Mexico City, CDMX 14050
    Mexico

    Active - Recruiting

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, Dolnoslaskie 52-210
    Poland

    Site Not Available

  • Centrum Medyczne Neuromed

    Bydgoszcz, Kujawsko-pomorskie 85-163
    Poland

    Active - Recruiting

  • Twoja Przychodnia Nowosolskie Centrum Medyczne

    Nowa Sol, Lubuskie 67-100
    Poland

    Active - Recruiting

  • Centermed Kraków Sp. Z o.o.

    Krakow, Malopolska 31-530
    Poland

    Active - Recruiting

  • Concept Medica

    Warszawa, Mazowieckie 00-773
    Poland

    Active - Recruiting

  • Dr Sekowska Leczenie Bolu

    Warszawa, Mazowieckie 01-018
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Damiana Walbrzyska

    Warszawa, Mazowieckie 02-739
    Poland

    Active - Recruiting

  • Instytut Zdrowia

    Oświęcim, Małopolska 32-600
    Poland

    Active - Recruiting

  • Centrum Leczenia Bolu dr n med Lukasz Kmieciak

    Łódź, Łódzkie 91-363
    Poland

    Active - Recruiting

  • Headache Management Centre

    Łódź, Łódzkie 91-363
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081
    Poland

    Active - Recruiting

  • Vita Longa Sp. Z o.o.

    Katowice, 40-748
    Poland

    Active - Recruiting

  • Centermed Kraków Sp. Z o.o.

    Kraków, 31-530
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Szczecin

    Szczecin, 70-784
    Poland

    Active - Recruiting

  • MTZ Clinical Research Powered by Pratia

    Warszawa, 02-172
    Poland

    Site Not Available

  • Praktyka Lekarska

    Warszawa, 00-144
    Poland

    Active - Recruiting

  • Centrum Medyczne OPOROW

    Wroclaw, 52-416
    Poland

    Active - Recruiting

  • Premium Clinic Wrocław

    Wroclaw, 50-414
    Poland

    Active - Recruiting

  • Hospital Universitario de Elda

    Elda, Alicante 03600
    Spain

    Active - Recruiting

  • Complejo Hospitalario Ruber Juan Bravo

    Madrid, Madrid, Comunidad DE 28006
    Spain

    Site Not Available

  • Hospital de la Princesa

    Madrid, Madrid, Comunidad DE 28006
    Spain

    Site Not Available

  • Hospital HM Sanchinarro

    Sanchinarro, Madrid, Comunidad DE 28050
    Spain

    Active - Recruiting

  • Hospital General de Valencia

    Valencia, València 46014
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona Plato Headquarters

    Barcelona, 08006
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario de La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Universitario Ruber Juan Bravo

    Salamanca, Madrid, 28006
    Spain

    Site Not Available

  • University Hospital Marqués de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Virgen del Rocio University Hospital

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Consorcio Hospital General Universitario

    Valencia, 46014
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47010
    Spain

    Active - Recruiting

  • Hospital Universitario de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • CTC Karolinska

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

    Site Not Available

  • CTC Solna

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

    Active - Recruiting

  • CTC MTC

    Uppsala, Uppsala LÄN [se-03] 752 37
    Sweden

    Active - Recruiting

  • CTC Uppsala

    Uppsala, Uppsala LÄN [se-03] 75237
    Sweden

    Site Not Available

  • Carlanderska Hospital

    Goteborg, 40545
    Sweden

    Site Not Available

  • Carlanderska Hospital

    Gothenburg, 41255
    Sweden

    Active - Recruiting

  • Skåneuro Privatmottagning

    Lund, 222 22
    Sweden

    Active - Recruiting

  • Akardo Med Site

    Stockholm, 117 27
    Sweden

    Site Not Available

  • Hälsoklustret

    Stockholm, 112 39
    Sweden

    Active - Recruiting

  • University Hospital Uppsala (VO Neuro)

    Uppsala, 75185
    Sweden

    Active - Recruiting

  • Cognition Health - Birmingham

    Edgbaston, Birmingham B16 8LT
    United Kingdom

    Site Not Available

  • Cognition Health - Birmingham

    Edgebaston, Birmingham B16 8LT
    United Kingdom

    Site Not Available

  • Re: Cognition Health Ltd.

    Edgebaston, Birmingham B16 8LT
    United Kingdom

    Site Not Available

  • 4 Medical Clinical Solutions London

    Ilford, Essex IG1 4HP
    United Kingdom

    Site Not Available

  • James Paget University Hospitals NHS Foundation Trust

    Great Yarmouth, Norfolk NR31 6LA
    United Kingdom

    Site Not Available

  • Lakeside Healthcare Group Research

    Corby, Northamptonshire NN17 2UR
    United Kingdom

    Active - Recruiting

  • James Paget University Hospital

    Great Yarmouth, Other NR31 6LA
    United Kingdom

    Site Not Available

  • The Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire OX3 9DU
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, Scotland G51 4TF
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Birmingham

    Birmingham, B16 8LT
    United Kingdom

    Site Not Available

  • Cognition Health - Bristol

    Bristol, BS32 4SY
    United Kingdom

    Site Not Available

  • Hull University Hospitals NHS Trust

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • The Walton Centre NHS Foundation Trust

    Liverpool, L9 7LJ
    United Kingdom

    Site Not Available

  • 4 Medical Clinical Solutions London

    London, IG1 4HP
    United Kingdom

    Site Not Available

  • Kings College London

    London, WC2R 2LS
    United Kingdom

    Site Not Available

  • South Tyneside and Sunderland NHS Foundation Trust

    Sunderland, Tyne & Wear, SR4 7TP
    United Kingdom

    Site Not Available

  • 4 Medical Clinical Solutions

    Swinton, Manchester, M27 8FF
    United Kingdom

    Active - Recruiting

  • Clinical Research Institute

    Los Angeles, California 90048
    United States

    Site Not Available

  • California Neuroscience Research, LLC

    Sherman Oaks, California 91403
    United States

    Active - Recruiting

  • Ki Health Partners LLC, dba New England Institute for Clinical Research

    Stamford, Connecticut 06905
    United States

    Active - Recruiting

  • Complete Health Research

    Edgewater, Florida 32132
    United States

    Site Not Available

  • Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit

    Edgewater, Florida 32132
    United States

    Terminated

  • Wr-Msra,Llc

    Lake City, Florida 32055
    United States

    Terminated

  • AppleMed Research Group, LLC

    Miami, Florida 33126
    United States

    Active - Recruiting

  • Sensible Healthcare LLC

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Complete Health Research

    Ormond Beach, Florida 32174
    United States

    Active - Recruiting

  • Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit

    Ormond Beach, Florida 32174
    United States

    Terminated

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Terminated

  • Community Clinical Research Network, Inc.

    Marlborough, Massachusetts 01752
    United States

    Active - Recruiting

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Active - Recruiting

  • Rochester Medical Group

    Rochester Hills, Michigan 48098
    United States

    Active - Recruiting

  • DM Clinical Research - Detroit, MI

    Southfield, Michigan 48076
    United States

    Site Not Available

  • StudyMetrix Research

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Clinvest Research, LLC

    Springfield, Missouri 65810
    United States

    Site Not Available

  • St Charles Clinical Research

    Weldon Spring, Missouri 63304
    United States

    Active - Recruiting

  • Wr-Crcn, Llc

    Las Vegas, Nevada 89118
    United States

    Active - Recruiting

  • Albuquerque Clinical Trials. Inc.

    Albuquerque, New Mexico 87102
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • DM Clinical Research - Brooklyn

    Brooklyn, New York 11220
    United States

    Site Not Available

  • DM Clinical Research - NY, NY

    Brooklyn, New York 11220
    United States

    Site Not Available

  • DiGiovanna Institute for Medical Education And Research

    North Massapequa, New York 11758-1853
    United States

    Terminated

  • Headache Wellness Center, PC

    Greensboro, North Carolina 27405
    United States

    Active - Recruiting

  • M3 Wake Research

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc. - Anderson

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Alliance for Multispecialty Reseach, LLC

    Knoxville, Tennessee 37909
    United States

    Terminated

  • Red Star Research, LLC

    Lake Jackson, Texas 77566
    United States

    Active - Recruiting

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Active - Recruiting

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