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

April 11, 2024 updated by: Pfizer

A Phase 4, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With a History of Inadequate Response to Oral Preventive Medications

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Broadmeadow, New South Wales, Australia, 2292
        • Not yet recruiting
        • Genesis Research Services
      • Newcastle, New South Wales, Australia, 2292
        • Not yet recruiting
        • Genesis Research Services
    • Queensland
      • Sippy Downs, Queensland, Australia, 4556
        • Recruiting
        • USC Clinical Trials Sunshine Coast
    • South Australia
      • Wayville, South Australia, Australia, 5034
        • Not yet recruiting
        • PainMedSA & CerCare Pty Ltd
  • Austria
      • Klagenfurt am Wörthersee, Austria, 9020
        • Not yet recruiting
        • Klinikum Klagenfurt am Wörthersee
      • Vienna, Austria, 1090
        • Not yet recruiting
        • Medical University of Vienna
      • Vienna, Austria, A-1090
        • Not yet recruiting
        • Medical University of Vienna
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Not yet recruiting
        • Medical University Innsbruck
  • Belgium
      • Antwerpen, Belgium, 2610
        • Recruiting
        • GZA ziekenhuizen
      • Brugge, Belgium, 8000
        • Not yet recruiting
        • AZ Sint-Jan
      • Brugge, Belgium, 8000
        • Not yet recruiting
        • AZ Sint-Jan Brugge-Oostende AV
      • Brussel, Belgium, 1090
        • Not yet recruiting
        • UZ Brussel
      • Hasselt, Belgium, 3500
        • Recruiting
        • Jessa Ziekenhuis
      • Liège, Belgium, 4000
        • Recruiting
        • Clinique de la Citadelle
      • Saint Nicolas Province De Liège, Belgium, 4420
        • Recruiting
        • Cabinet Privé Dr. Simona Sava
    • Brussels
      • Jette, Brussels, Belgium, 1090
        • Recruiting
        • UZ Brussel
  • Canada
      • Quebec, Canada, G3K 2P8
        • Recruiting
        • ALPHA Recherche Clinique
      • Quebec, Canada, G2J 0C4
        • Recruiting
        • ALPHA Recherche Clinique
    • Ontario
      • Brampton, Ontario, Canada, L6V 1C2
        • Recruiting
        • NeuPath Centre for Pain and Spine
    • Quebec
      • Levis, Quebec, Canada, G6W 0M5
        • Not yet recruiting
        • Clinique Neuro-Lévis
      • Levis, Quebec, Canada, G6W0M5
        • Recruiting
        • Centre de Recherche Saint-Louis/Clinique Neuro-Levis
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • Not yet recruiting
        • DIEX Recherche Sherbrooke Inc.
  • Denmark
      • Copenhagen, Denmark, 2400
        • Not yet recruiting
        • Bispebjerg Hospital
    • Capital Region
      • Copenhagen NV, Capital Region, Denmark, 2400
        • Not yet recruiting
        • Bispebjerg Hospital
    • Region Hovedstaden
      • Glostrup, Region Hovedstaden, Denmark, 2600
        • Recruiting
        • Danish Headache Center
  • Finland
      • Helsinki, Finland, 00100
        • Not yet recruiting
        • Terveystalo Oy
      • Helsinki, Finland, 00180
        • Recruiting
        • Terveystalo Ruoholahti
      • Tampere, Finland, 33100
        • Recruiting
        • Terveystalo Tampere
      • Turku, Finland, 20100
        • Recruiting
        • Terveystalo Pulssi
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00180
        • Recruiting
        • Terveystalo Ruoholahti
  • Germany
      • Bad Homburg Hessen, Germany, 61348
        • Not yet recruiting
        • Zentrum für klinische Forschung
      • Berlin, Germany, 10827
        • Not yet recruiting
        • Neurozentrum Tempelhof Berlin
      • Berlin, Germany, 12672
        • Not yet recruiting
        • Synexus - Prüfzentrum Berlin
      • Böhlen Sachsen, Germany, 04564
        • Not yet recruiting
        • Studiumzentrum Dr. A. Schwittay
      • Frankfurt, Germany, 65929
        • Not yet recruiting
        • Kopfschmerzzentrum Frankfurt
      • Greifswald, Germany, 17475
        • Not yet recruiting
        • Universitätsmedizin Greifswald
      • Ulm Baden-Wuerttemberg, Germany, 89073
        • Not yet recruiting
        • Neuropoint GmbH
      • Westerstede, Germany, 26655
        • Not yet recruiting
        • Studienzentrum Nordwest
      • Wiesbaden Hessen, Germany, 65189
        • Not yet recruiting
        • Intermed GmbH
    • Baden-wuerttemberg
      • Göppingen, Baden-wuerttemberg, Germany, 73033
        • Not yet recruiting
        • Schmerz- und Palliativzentrum Göppingen
    • Hessen
      • Bad Homburg, Hessen, Germany, 61350
        • Not yet recruiting
        • Zentrum für klinische Forschung
      • Frankfurt am Main, Hessen, Germany, 60313
        • Not yet recruiting
        • Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre
      • Wiesbaden, Hessen, Germany, 65189
        • Not yet recruiting
        • Intermed GmbH
    • Niedersachsen
      • Westerstede, Niedersachsen, Germany, 26655
        • Not yet recruiting
        • Studienzentrum Nordwest
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • Synexus - Prüfzentrum Leipzig
  • Italy
      • Florence, Italy, 50134
        • Recruiting
        • SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
      • Milan, Italy, 20133
        • Not yet recruiting
        • IRCCS Fondazione Besta
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione Mondino - Istituto Neurologico Nazionale IRCCS
      • Rome, Italy, 00197
        • Recruiting
        • IRCCS San Raffaele Roma
    • MI
      • Milano, MI, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele
      • Milano, MI, Italy, 20132
        • Not yet recruiting
        • IRCCS Ospedale San Raffaele
    • Naples
      • Napoli, Naples, Italy, 80138
        • Recruiting
        • AOU Luigi Vanvitelli
    • Pavia
      • Pavia (PV), Pavia, Italy, 27100
        • Recruiting
        • Clinical Trial Center IRCCS Mondino
  • Mexico
      • Aguascalientes, Mexico, 20116
        • Not yet recruiting
        • Centro de Investigación Médica de Aguascalientes (CIMA)
      • Mexico City, Mexico, CDMX 06700
        • Recruiting
        • Clinstile, SA de CV
      • Mexico City, Mexico, CDMX 14050
        • Recruiting
        • Unidad de Investigación En Salud de Chihuahua Sc
    • Estado DE Mexico
      • Cuautitlan Izcalli, Estado DE Mexico, Mexico, 54769
        • Not yet recruiting
        • Phylasis Clinicas Research S. de R.L. de C.V.
      • Tlalnepantla de Baz, Estado DE Mexico, Mexico, 54055
        • Recruiting
        • Clinical Research Institute S.C.
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Not yet recruiting
        • Medical Care and Research S.A. de C.V.
  • Poland
      • Katowice, Poland, 40-748
        • Recruiting
        • Vita Longa Sp. z o.o.
      • Katowice, Poland, 40-081
        • Recruiting
        • Centrum Medyczne Pratia Katowice
      • Kraków, Poland, 31-530
        • Recruiting
        • Centermed Kraków Sp. Z o.o.
      • Szczecin, Poland, 70-784
        • Not yet recruiting
        • MICS Centrum Medyczne Szczecin
      • Warszawa, Poland, 00-144
        • Recruiting
        • Praktyka Lekarska
      • Warszawa, Poland, 00-144
        • Recruiting
        • Dr Sekowska Leczenie Bolu
      • Wroclaw, Poland, 52-416
        • Recruiting
        • Centrum Medyczne Oporow
      • Wroclaw, Poland, 50-414
        • Recruiting
        • Premium Clinic Wrocław
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-163
        • Recruiting
        • Centrum Medyczne Neuromed
    • Lubuskie
      • Nowa Sol, Lubuskie, Poland, 67-100
        • Recruiting
        • Twoja Przychodnia Nowosolskie Centrum Medyczne
    • Malopolska
      • Krakow, Malopolska, Poland, 31-530
        • Recruiting
        • Centermed Kraków Sp. Z o.o.
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 00-773
        • Recruiting
        • Concept Medica
      • Warszawa, Mazowieckie, Poland, 02-739
        • Not yet recruiting
        • MICS Centrum Medyczne Damiana Walbrzyska
    • Małopolska
      • Oświęcim, Małopolska, Poland, 32-600
        • Recruiting
        • Instytut Zdrowia
    • Łódzkie
      • Łódź, Łódzkie, Poland, 91-363
        • Recruiting
        • Centrum Leczenia Bolu dr n med Lukasz Kmieciak
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08006
        • Recruiting
        • Hospital Clinic de Barcelona Plato Headquarters
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital HM Sanchinarro
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro
      • Santander, Spain, 39008
        • Recruiting
        • University Hospital Marqués de Valdecilla
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain, 41013
        • Recruiting
        • Virgen del Rocío University Hospital
      • Sevilla, Spain, 41013
        • Not yet recruiting
        • Virgen del Rocío University Hospital
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain, 46014
        • Not yet recruiting
        • Consorcio Hospital General Universitario
      • Valencia, Spain, 46014
        • Recruiting
        • Consorcio Hospital General Universitario
      • Valladolid, Spain, 47010
        • Recruiting
        • Hospital Clínico Universitario de Valladolid
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Universitario de Valladolid
    • Alicante
      • Elda, Alicante, Spain, 03600
        • Recruiting
        • Hospital Universitario de Elda
    • Madrid, Comunidad DE
      • Madrid, Madrid, Comunidad DE, Spain, 28006
        • Not yet recruiting
        • Hospital de La Princesa
      • Sanchinarro, Madrid, Comunidad DE, Spain, 28050
        • Recruiting
        • Hospital HM Sanchinarro
    • València
      • Valencia, València, Spain, 46014
        • Not yet recruiting
        • Hospital General de Valencia
  • Sweden
      • Goteborg, Sweden, 40545
        • Recruiting
        • Carlanderska Hospital
      • Gothenburg, Sweden, 41255
        • Recruiting
        • Carlanderska Hospital
      • Lund, Sweden, 222 22
        • Recruiting
        • Skaneuro Privatmottagning
      • Stockholm, Sweden, 117 27
        • Not yet recruiting
        • Akardo Med Site
      • Stockholm, Sweden, 112 39
        • Not yet recruiting
        • Hälsoklustret
      • Stockholm, Sweden, 117 27
        • Recruiting
        • Akardo Med Site
      • Uppsala, Sweden, 752 37
        • Not yet recruiting
        • CTC Uppsala
      • Uppsala, Sweden, 75185
        • Recruiting
        • University Hospital Uppsala (VO Neuro)
    • Stockholms LÄN [se-01]
      • Solna, Stockholms LÄN [se-01], Sweden, 171 64
        • Recruiting
        • CTC Solna
    • Uppsala LÄN [se-03]
      • Uppsala, Uppsala LÄN [se-03], Sweden, 752 37
        • Recruiting
        • CTC MTC
      • Uppsala, Uppsala LÄN [se-03], Sweden, 75237
        • Not yet recruiting
        • CTC Uppsala
  • United Kingdom
      • Birmingham, United Kingdom, B16 8LT
        • Not yet recruiting
        • Re:Cognition Health - Birmingham
      • Bristol, United Kingdom, BS232 4SY
        • Not yet recruiting
        • Cognition Health - Bristol
      • Bristol, United Kingdom, BS32 4SY
        • Not yet recruiting
        • Cognition Health - Bristol
      • Hull, United Kingdom, HU3 2JZ
        • Not yet recruiting
        • Hull University Hospitals NHS Trust
      • Liverpool, United Kingdom, L9 7LJ
        • Not yet recruiting
        • The Walton Centre NHS Foundation Trust
      • Swinton, Manchester, United Kingdom, M27 8FF
        • Not yet recruiting
        • 4 Medical Clinical Solutions
    • Birmingham
      • Edgbaston, Birmingham, United Kingdom, B16 8LT
        • Not yet recruiting
        • Cognition Health - Birmingham
      • Edgebaston, Birmingham, United Kingdom, B16 8LT
        • Not yet recruiting
        • Cognition Health - Birmingham
    • EAST Riding
      • Hull, EAST Riding, United Kingdom, HU3 2J2
        • Not yet recruiting
        • Hull University Hospitals NHS Trust
    • Norfolk
      • Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
        • Not yet recruiting
        • James Paget University Hospital
    • Northamptonshire
      • Corby, Northamptonshire, United Kingdom, NN17 2UR
        • Not yet recruiting
        • Lakeside Healthcare Group Research
    • Other
      • Great Yarmouth, Other, United Kingdom, NR31 6LA
        • Not yet recruiting
        • James Paget University Hospital
  • United States
    • California
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • California Neuroscience Research, LLC
        • Contact:
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Recruiting
        • Ki Health Partners LLC, dba New England Institute for Clinical Research
    • Florida
      • Edgewater, Florida, United States, 32132
        • Not yet recruiting
        • Complete Health Research
      • Edgewater, Florida, United States, 32132
        • Recruiting
        • Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit
      • Lake City, Florida, United States, 32055
      • Miami, Florida, United States, 33126
        • Recruiting
        • AppleMed Research Group, LLC
        • Contact:
      • Ormond Beach, Florida, United States, 32174
        • Recruiting
        • Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Recruiting
        • Boston Clinical Trials
      • Marlborough, Massachusetts, United States, 01752
        • Recruiting
        • Community Clinical Research Network, Inc.
    • Missouri
      • Saint Peters, Missouri, United States, 63303
        • Not yet recruiting
        • StudyMetrix Research
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Clinvest Research, LLC
      • Springfield, Missouri, United States, 65810
        • Not yet recruiting
        • Clinvest Research, LLC
      • Weldon Spring, Missouri, United States, 63304
        • Recruiting
        • St Charles Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89118
        • Recruiting
        • Wr-Crcn, Llc
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • Albuquerque Clinical Trials. Inc.
    • New York
      • Bronx, New York, United States, 10461
        • Not yet recruiting
        • Montefiore Medical Center
      • North Massapequa, New York, United States, 11758-1853
        • Not yet recruiting
        • DiGiovanna Institute for Medical Education and Research
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Headache Wellness Center, PC
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • Alliance for Multispecialty Reseach, LLC
    • Texas
      • Lake Jackson, Texas, United States, 77566
        • Recruiting
        • Red Star Research, LLC
      • Tomball, Texas, United States, 77375
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years 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 the Screening 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/cluster headaches. Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered, migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication).

Exclusion Criteria:

  1. History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.
  2. Current medication overuse headaches.
  3. 15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the 28- day Observation Phase.
  4. Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across > 4 categories of recognized, orally administered, migraine-preventive medications.
  5. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS]).
  6. Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Matching placebo with every other day dosing during DBT phase
Experimental: Rimegepant 75 mg
Drug: Rimegepant
Rimegepant 75 mg Oral Disintegrating Tablet (ODT) taken every other day during Double-blind Treatment (DBT) phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the efficacy of rimegepant (75 mg) to placebo
Time Frame: Week 1 to 12 of DBT Phase
Subjects are dosed every other day, for the preventative treatment of migraine as measured by mean change in number of migraine days per month (28 days) over 12 week DBT Phase. A migraine day is any calendar day in which the subject experiences a qualified migraine headache. This includes any calendar day in which the subject takes an acute migraine-specific medication.
Week 1 to 12 of DBT Phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2022

Primary Completion (Estimated)

February 10, 2025

Study Completion (Estimated)

February 10, 2025

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV3000-407 (Registry Identifier: CTIS (EU))
  • 2022-001176-34 (Registry Identifier: CTIS (EU))
  • C4951012 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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