Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

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

Phase

4

Condition

Oral Facial Pain

Pain (Pediatric)

Chronic Pain

Treatment

Rimegepant

Placebo

Clinical Study ID

NCT05509400
BHV3000-406
2024-513269-37-00
2022-001175-14
C4951004
  • Ages > 18
  • All Genders

Study Summary

This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

  • 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).

  • Less than 15 headache days (migraine or non-migraine) per month in each of the 3months prior to the Screening Visit and throughout the Screening Phase.

  • Subjects must be able to distinguish migraine attacks from tension/clusterheadaches.

  • Subjects on prophylactic migraine medication (excluding CGRP antagonists) arepermitted to remain on therapy if they have been on a stable dose for at least 3months (12 weeks) prior to the Screening Visit, and if the dose is not expected tochange during the course of the study.

  • Triptan unsuitable

Exclusion

Exclusion Criteria:

-Target Disease Exclusion:

  1. History of cluster headache, basilar migraine, or hemiplegic migraine

  2. Current medication overuse headaches

  3. Headaches occurring 15 or more days per month (migraine or non-migraine) in any ofthe 3 months prior to the Screening Visit

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

  5. 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:
October 18, 2022
Estimated Completion Date:
August 25, 2025

Study Description

This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease). Rimegepant will be further evaluated in this population with as needed use in a 12-week, open-label extension study.

Connect with a study center

  • USC Clinical Trials Centre

    Sippy Downs, Queensland 4556
    Australia

    Active - Recruiting

  • CerCare Pty Ltd

    Wayville, South Australia 5034
    Australia

    Site Not Available

  • CerCare SA

    Wayville, South Australia 5034
    Australia

    Site Not Available

  • PainMedSA & CerCare Pty Ltd

    Wayville, South Australia 5034
    Australia

    Site Not Available

  • Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt am Wörthersee, Carinthia 9020
    Austria

    Active - Recruiting

  • Medical University Innsbruck

    Innsbruck, Tirol 6020
    Austria

    Active - Recruiting

  • Medical University of Vienna

    Vienna, 1090
    Austria

    Site Not Available

  • Cabinet Privé Dr. Simona Sava

    Saint Nicolas, Liège 4420
    Belgium

    Active - Recruiting

  • GZA Ziekenhuizen

    Antwerpen, 2610
    Belgium

    Active - Recruiting

  • UZ Brussel

    Brussels, 1090
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • Jessa Ziekenhuis

    Hasselt, 3500
    Belgium

    Active - Recruiting

  • Cabinet Privé Dr. Simona Sava

    Saint Nicolas Province De Liège, 4420
    Belgium

    Site Not Available

  • University of Calgary South Health Campus

    Calgary, Alberta T3M 1M4
    Canada

    Active - Recruiting

  • Aggarwal and Associates Limited

    Brampton, Ontario L6T 0G1
    Canada

    Active - Recruiting

  • NeuPath Centre for Pain and Spine

    Brampton, Ontario L6V 1C2
    Canada

    Site Not Available

  • Clinique Neuro-Lévis

    Levis, Quebec G6W 0M5
    Canada

    Active - Recruiting

  • ALPHA Recherche Clinique

    Quebec, G2J 0C4
    Canada

    Active - Recruiting

  • Alpha Recherche Clinique

    Quebec, G3K 2P8
    Canada

    Active - Recruiting

  • Bispebjerg Hospital

    Copenhagen NV, Capital Region 2400
    Denmark

    Site Not Available

  • Bispebjerg Hospital

    Copenhagen, 2400
    Denmark

    Site Not Available

  • University Hospital of Southern Denmark

    Esbjerg, DK-6700
    Denmark

    Site Not Available

  • Danish Headache Center

    Glostrup, 2600
    Denmark

    Active - Recruiting

  • Hospitalsenhed Midt

    Viborg, DK-8800
    Denmark

    Active - Recruiting

  • Helsinki Headache Center

    Helsinki, Uusimaa 830
    Finland

    Site Not Available

  • Terveystalo Ruoholahti

    Helsinki,
    Finland

    Active - Recruiting

  • Terveystalo Tampere

    Tampere, 33100
    Finland

    Site Not Available

  • Terveystalo Tampere Rautatienkatu

    Tampere, 33100
    Finland

    Active - Recruiting

  • Terveystalo Pulssi

    Turku, 20100
    Finland

    Active - Recruiting

  • CHU Saint-Etienne, Hopital Nord

    Saint Priest en Jarez, Loire 42270
    France

    Site Not Available

  • Timone Hospital

    Marseille, Provence 13005
    France

    Active - Recruiting

  • CHU Lyon Hôpital Pierre Wertheimer

    Bron, 69677
    France

    Site Not Available

  • Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer

    Bron, 69500
    France

    Active - Recruiting

  • CHU Clermont Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • Centre Hospitalier Annecy Genevois

    Epagny Metz-Tessy, 74370
    France

    Active - Recruiting

  • CHU de Lille - Hôpital Salengro

    Lille, 59037
    France

    Active - Recruiting

  • CHU Nice Hopital Cimiez

    Nice, 06000
    France

    Active - Recruiting

  • Hopital Lariboisiere

    Paris, 75010
    France

    Active - Recruiting

  • CHU Saint-Etienne - Hopital Nord

    Saint-Etienne Cedex 2, 42055
    France

    Active - Recruiting

  • Vitos Orthopaedische Klinik Kassel

    Kassel, Hessen 34131
    Germany

    Site Not Available

  • Charité Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Charité Universitätsmedizin Berlin, Neurologische Ambulanz, Kopfschmerzambulanz

    Berlin, 10117
    Germany

    Active - Recruiting

  • Kopfschmerzzentrum Frankfurt

    Frankfurt, 65929
    Germany

    Active - Recruiting

  • Universitätsmedizin Greifswald

    Greifswald, 17475
    Germany

    Site Not Available

  • University Hospital Jena

    Jena, 07747
    Germany

    Site Not Available

  • Neurologische Praxis Prof. Dr. Hartmut Gobel

    Kiel, 24194
    Germany

    Site Not Available

  • Schmerzklinik Kiel

    Kiel, 24149
    Germany

    Site Not Available

  • Helios DKD Hospital Wiesbaden

    Wiesbaden, 65191
    Germany

    Site Not Available

  • IRCCS Ospedale San Raffaele

    Milano, MI 20132
    Italy

    Active - Recruiting

  • AOU Luigi Vanvitelli

    Napoli, Naples 80138
    Italy

    Active - Recruiting

  • Policlinico di Bari

    Bari, Puglia 70124
    Italy

    Site Not Available

  • Fondazione Policlinico Campus BioMedico

    Rome, RM 00128
    Italy

    Active - Recruiting

  • IRCCS San Raffaele Roma

    Roma, Rome 00163
    Italy

    Site Not Available

  • Foundation IRCCS Neurological Institute Carlo Besta

    Milano, 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

  • Headache and Pain Unit - IRCCS San Raffaele

    Rome, 00163
    Italy

    Active - Recruiting

  • Clinical Research Institute S.C.

    Tlalnepantla de Baz, Estado DE Mexico 54055
    Mexico

    Active - Recruiting

  • 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

    Site Not Available

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, Dolnoslaskie 52-210
    Poland

    Active - Recruiting

  • Centrum Medyczne Neuromed

    Bydgoszcz, Kujawsko-pomorskie 85-163
    Poland

    Active - Recruiting

  • Twoja Przychodnia Nowosolskie Centrum Medyczne

    Nowa Sol, Lubuskie 67-100
    Poland

    Active - Recruiting

  • Concept Medica

    Warszawa, Mazowieckie 00-773
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Damiana Walbrzyska

    Warszawa, Mazowieckie 02-739
    Poland

    Active - Recruiting

  • Instytut Zdrowia

    Oświęcim, Małopolska 32-600
    Poland

    Site Not Available

  • Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k.

    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

  • Vita Longa Sp. Z o.o.

    Katowice, 40-748
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Szczecin

    Szczecin, 70-784
    Poland

    Active - Recruiting

  • MTZ Clinical Research Powered by Pratia

    Warsaw, 02-127
    Poland

    Site Not Available

  • MTZ Clinical Research Powered by Pratia

    Warszawa, 02-172
    Poland

    Site Not Available

  • Praktyka Lekarska

    Warszawa, 00-144
    Poland

    Active - Recruiting

  • University Hospital Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Complejo Hospitalario Ruber Juan Bravo

    Madrid, 28006
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Ruber Juan Bravo

    Salamanca, Madrid, 28006
    Spain

    Site Not Available

  • Virgen del Rocio University Hospital

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • CTC AB

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

    Site Not Available

  • CTC Solna

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

    Active - Recruiting

  • CTC Uppsala

    Uppsala, Uppsala LÄN 752 37
    Sweden

    Active - Recruiting

  • Skåneuro Privatmottagning

    Lund, 222 22
    Sweden

    Active - Recruiting

  • CTC AB

    Solna Stockholm, 171 64
    Sweden

    Site Not Available

  • Akardo MedSite

    Stockholm, 117 27
    Sweden

    Active - Recruiting

  • Hälsoklustret

    Stockholm, 112 39
    Sweden

    Active - Recruiting

  • Cognition Health - Birmingham

    Edgebaston, Birmingham B16 8LT
    United Kingdom

    Site Not Available

  • Re: Cognition Health Ltd.

    Edgebaston, Birmingham B16 8LT
    United Kingdom

    Active - Recruiting

  • 4 Medical Clinical Solutions London

    Ilford, Essex IG1 4HP
    United Kingdom

    Site Not Available

  • Lakeside Healthcare Group Research

    Corby, Northamptonshire NN17 2UR
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire OX3 9DU
    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

    Active - Recruiting

  • 4 Medical Clinical Solutions

    Swinton, Manchester, M27 8FF
    United Kingdom

    Active - Recruiting

  • Clinical Research Institute

    Los Angeles, California 90048
    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

    Site Not Available

  • 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

    Active - Recruiting

  • 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

  • WR-Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Collective Medical Research

    Overland Park, Kansas 66210
    United States

    Active - Recruiting

  • DelRicht Research

    New Orleans, Louisiana 70124
    United States

    Active - Recruiting

  • 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

    Southfield, Michigan 48076
    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 65807
    United States

    Active - Recruiting

  • St Charles Clinical Research

    Weldon Spring, Missouri 63304
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Terminated

  • DM Clinical Research - NY, NY

    Brooklyn, New York 11220
    United States

    Site Not Available

  • New York Neurology Associates

    New York, New York 10003
    United States

    Terminated

  • DiGiovanna Institute for Medical Education And Research

    North Massapequa, New York 11758-1853
    United States

    Site Not Available

  • Headache Wellness Center, PC

    Greensboro, North Carolina 27405
    United States

    Active - Recruiting

  • Synexus Clinical Research US, Inc. - Anderson

    Anderson, South Carolina 29621
    United States

    Active - Recruiting

  • 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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