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

Last updated: July 16, 2025
Sponsor: Pfizer
Overall Status: Completed

Phase

4

Condition

Chronic Pain

Pain (Pediatric)

Migraine (Adult)

Treatment

Placebo

Rimegepant

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: 658
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
November 07, 2022
Estimated Completion Date:
July 08, 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

    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

  • Medical University Innsbruck

    Innsbruck, Tirol 6020
    Austria

    Site Not Available

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt am Wörthersee, 9020
    Austria

    Site Not Available

  • Medical University of Vienna

    Vienna, 1090
    Austria

    Site Not Available

  • UZ Brussel

    Jette, Brussels 1090
    Belgium

    Site Not Available

  • GZA Ziekenhuizen

    Antwerpen, 2610
    Belgium

    Site Not Available

  • AZ Sint-Jan

    Brugge, 8000
    Belgium

    Site Not Available

  • AZ Sint-Jan Brugge-Oostende AV

    Brugge, 8000
    Belgium

    Site Not Available

  • UZ Brussel

    Brussel, 1090
    Belgium

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  • Jessa Ziekenhuis

    Hasselt, 3500
    Belgium

    Site Not Available

  • Clinique de la Citadelle

    Liège, 4000
    Belgium

    Site Not Available

  • Cabinet Privé Dr. Simona Sava

    Saint Nicolas Province De Liège, 4420
    Belgium

    Site Not Available

  • Aggarwal and Associates Limited

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • NeuPath Centre for Pain and Spine

    Brampton, Ontario L6V 1C2
    Canada

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

    Levis, Quebec G6W0M5
    Canada

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    Levis, Quebec G6W 0M5
    Canada

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    Sherbrooke, Quebec J1L 0H8
    Canada

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    Quebec, G3K 2P8
    Canada

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  • Bispebjerg Hospital

    Copenhagen NV, Capital Region 2400
    Denmark

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  • Danish Headache Center

    Glostrup, Region Hovedstaden 2600
    Denmark

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  • Bispebjerg Hospital

    Copenhagen, 2400
    Denmark

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  • University Hospital of Southern Denmark

    Esbjerg, DK-6700
    Denmark

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    Viborg, DK-8800
    Denmark

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    Helsinki, Uusimaa 00180
    Finland

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    Helsinki, 00100
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    Tampere, 33100
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    Turku, 20100
    Finland

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    Göppingen, Baden-wuerttemberg 73033
    Germany

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    Bad Homburg, Hessen 61350
    Germany

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    Frankfurt, Hessen 65929
    Germany

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  • Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre

    Frankfurt am Main, Hessen 60313
    Germany

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    Wiesbaden, Hessen 65189
    Germany

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  • Universitätsmedizin Greifswald

    Greifswald, Mecklenburg-vorpommern 17475
    Germany

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    Westerstede, Niedersachsen 26655
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    Bad Homburg Hessen, 61348
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    Berlin, 10827
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    Berlin, 12672
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    Böhlen Sachsen, 04564
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    Ulm Baden-Wuerttemberg, 89073
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    Wiesbaden Hessen, 65189
    Germany

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  • IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino

    Pavia, Lombardia 27100
    Italy

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    Milano, MI 20132
    Italy

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    Milano, MI 20132
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    Modena, Emilia-Romagna, Modena 41124
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    Napoli, Naples 80134
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    Rome, RM 00128
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    Rome, Rome/lazio 00163
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  • SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi

    Florence, 50134
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    Milan, 20133
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  • University Modena e Reggio Emilia

    Modena, 41124
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    Rome, 00197
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    Alcadia Tlalpan, Ciudad DE Mexico C.P. 14050
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  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, Dolnoslaskie 52-210
    Poland

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    Bydgoszcz, Kujawsko-pomorskie 85-163
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    Oświęcim, Małopolska 32-600
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    Łódź, Łódzkie 91-363
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    Wroclaw, 52-416
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    Wroclaw, 50-414
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  • Hospital Universitario de Elda

    Elda, Alicante 03600
    Spain

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    Madrid, Madrid, Comunidad DE 28006
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    Madrid, Madrid, Comunidad DE 28006
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    Sanchinarro, Madrid, Comunidad DE 28050
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    Valencia, València 46014
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    Barcelona, 08006
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    Barcelona, 08035
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    Madrid, 28050
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    Madrid, 28040
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    Madrid, 28046
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    Valencia, 46014
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    Valencia, 46010
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    Valladolid, 47010
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    Valladolid, 47003
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  • CTC Karolinska

    Solna, Stockholms LÄN [se-01] 171 64
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    Solna, Stockholms LÄN [se-01] 171 64
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    Uppsala, Uppsala LÄN [se-03] 752 37
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    Uppsala, Uppsala LÄN [se-03] 75237
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  • Carlanderska Hospital

    Goteborg, 40545
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    Gothenburg, 41255
    Sweden

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    Lund, 222 22
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  • Akardo Med Site

    Stockholm, 117 27
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    Stockholm, 112 39
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    Uppsala, 75185
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  • Cognition Health - Birmingham

    Edgbaston, Birmingham B16 8LT
    United Kingdom

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    Edgebaston, Birmingham B16 8LT
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    Edgebaston, Birmingham B16 8LT
    United Kingdom

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  • Hull University Hospitals NHS Trust

    Hull, EAST Riding HU3 2JZ
    United Kingdom

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    Ilford, Essex IG1 4HP
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  • James Paget University Hospitals NHS Foundation Trust

    Great Yarmouth, Norfolk NR31 6LA
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    Corby, Northamptonshire NN17 2UR
    United Kingdom

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  • James Paget University Hospital

    Great Yarmouth, Other NR31 6LA
    United Kingdom

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  • The Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire OX3 9DU
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    Glasgow, Scotland G51 4TF
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  • Re:Cognition Health - Birmingham

    Birmingham, B16 8LT
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  • Cognition Health - Bristol

    Bristol, BS32 4SY
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    Liverpool, L9 7LJ
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  • 4 Medical Clinical Solutions London

    London, IG1 4HP
    United Kingdom

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    London, SE5 9PJ
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  • South Tyneside and Sunderland NHS Foundation Trust

    Sunderland, Tyne & Wear, SR4 7TP
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  • 4 Medical Clinical Solutions

    Swinton, M27 8FF
    United Kingdom

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  • 4 Medical Clinical Solutions

    Swinton, Manchester, M27 8FF
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  • Clinical Research Institute

    Los Angeles, California 90048
    United States

    Site Not Available

  • California Neuroscience Research, LLC

    Sherman Oaks, California 91403
    United States

    Site Not Available

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

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • 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

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  • AppleMed Research Group, LLC

    Miami, Florida 33126
    United States

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    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

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  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

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  • Community Clinical Research Network, Inc.

    Marlborough, Massachusetts 01752
    United States

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  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan 48104
    United States

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    Rochester Hills, Michigan 48307
    United States

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    Southfield, Michigan 48076
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    Saint Peters, Missouri 63303
    United States

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    Springfield, Missouri 65807
    United States

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    Weldon Spring, Missouri 63304
    United States

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    Las Vegas, Nevada 89118
    United States

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    Albuquerque, New Mexico 87102
    United States

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    Bronx, New York 10461
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    Brooklyn, New York 11220
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    Brooklyn, New York 11220
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    North Massapequa, New York 11758
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    Greensboro, North Carolina 27405
    United States

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    Raleigh, North Carolina 27612
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    Anderson, South Carolina 29621
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    Knoxville, Tennessee 37909
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    Lake Jackson, Texas 77566
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    Tomball, Texas 77375
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    Bellevue, Washington 98007
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