Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications
NCT ID: NCT05518123
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
658 participants
INTERVENTIONAL
2022-11-07
2025-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Rimegepant 75 mg
Rimegepant
Rimegepant 75 mg Oral Disintegrating Tablet (ODT) taken every other day during Double-blind Treatment (DBT) phase
Placebo
Placebo
Matching placebo with every other day dosing during DBT phase
Interventions
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Rimegepant
Rimegepant 75 mg Oral Disintegrating Tablet (ODT) taken every other day during Double-blind Treatment (DBT) phase
Placebo
Matching placebo with every other day dosing during DBT phase
Eligibility Criteria
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Inclusion Criteria
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
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 first 28- days of the 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Clinical Research Institute
Los Angeles, California, United States
California Neuroscience Research, LLC
Sherman Oaks, California, United States
Ki Health Partners LLC, dba New England Institute for Clinical Research
Stamford, Connecticut, United States
Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit
Edgewater, Florida, United States
Wr-Msra,Llc
Lake City, Florida, United States
AppleMed Research Group, LLC
Miami, Florida, United States
Sensible Healthcare LLC
Ocoee, Florida, United States
Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit
Ormond Beach, Florida, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Community Clinical Research Network, Inc.
Marlborough, Massachusetts, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, United States
Rochester Medical Group
Rochester Hills, Michigan, United States
Clinvest Research, LLC
Springfield, Missouri, United States
St Charles Clinical Research
Weldon Spring, Missouri, United States
Wr-Crcn, Llc
Las Vegas, Nevada, United States
Albuquerque Clinical Trials. Inc.
Albuquerque, New Mexico, United States
DiGiovanna Institute for Medical Education And Research
North Massapequa, New York, United States
Headache Wellness Center, PC
Greensboro, North Carolina, United States
Synexus Clinical Research US, Inc. - Anderson
Anderson, South Carolina, United States
Alliance for Multispecialty Reseach, LLC
Knoxville, Tennessee, United States
Red Star Research, LLC
Lake Jackson, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
USC Clinical Trials Sunshine Coast
Sippy Downs, Queensland, Australia
Medical University Innsbruck
Innsbruck, Tyrol, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, , Austria
UZ Brussel
Jette, Brussels Capital, Belgium
GZA Ziekenhuizen
Antwerp, , Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
Clinique de la Citadelle
Liège, , Belgium
Cabinet Privé Dr. Simona Sava
Saint Nicolas Province de Liège, , Belgium
Aggarwal and Associates Limited
Brampton, Ontario, Canada
NeuPath Centre for Pain and Spine
Brampton, Ontario, Canada
Centre de Recherche Saint-Louis/Clinique Neuro-Levis
Lévis, Quebec, Canada
ALPHA Recherche Clinique
Québec, Quebec, Canada
ALPHA Recherche Clinique
Québec, , Canada
Bispebjerg Hospital
Copenhagen NV, Capital Region, Denmark
Danish Headache Center
Glostrup Municipality, Capital Region, Denmark
University Hospital of Southern Denmark
Esbjerg, , Denmark
Hospitalsenhed Midt
Viborg, , Denmark
Terveystalo Ruoholahti
Helsinki, Uusimaa, Finland
Terveystalo Tampere
Tampere, , Finland
Terveystalo Pulssi
Turku, , Finland
Schmerz- und Palliativzentrum Göppingen
Göppingen, Baden-Wurttemberg, Germany
Zentrum für klinische Forschung
Bad Homburg, Hesse, Germany
Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre
Frankfurt am Main, Hesse, Germany
Kopfschmerzzentrum Frankfurt
Frankfurt am Main, Hesse, Germany
Intermed GmbH
Wiesbaden, Hesse, Germany
Studienzentrum Nordwest
Westerstede, Lower Saxony, Germany
Synexus - Prüfzentrum Leipzig
Leipzig, Saxony, Germany
Synexus - Prüfzentrum Berlin
Berlin, , Germany
Neuropoint GmbH
Ulm Baden-Wuerttemberg, , Germany
IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino
Pavia, Lombardy, Italy
IRCCS Ospedale San Raffaele
Milan, MI, Italy
AOU Luigi Vanvitelli
Napoli, Naples, Italy
IRCCS San Raffaele
Rome, Rome/lazio, Italy
SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
Florence, , Italy
IRCCS Fondazione Besta
Milan, , Italy
University Modena e Reggio Emilia
Modena, , Italy
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, State of Mexico, Mexico
Clinical Research Institute S.C.
Tlalnepantla, State of Mexico, Mexico
Medical Care and Research S.A. de C.V.
Mérida, Yucatán, Mexico
Centro de Investigación Médica de Aguascalientes (CIMA)
Aguascalientes, , Mexico
Clinstile, SA de CV
Mexico City, , Mexico
Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv
Mexico City, , Mexico
Centrum Medyczne Neuromed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, Lower Silesian Voivodeship, Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, Lubusz Voivodeship, Poland
Centermed Kraków Sp. Z o.o.
Krakow, Malopolska, Poland
Concept Medica
Warsaw, Masovian Voivodeship, Poland
Dr Sekowska Leczenie Bolu
Warsaw, Masovian Voivodeship, Poland
MICS Centrum Medyczne Damiana Walbrzyska
Warsaw, Masovian Voivodeship, Poland
Instytut Zdrowia
Oświęcim, Małopolska, Poland
Centrum Medyczne Pratia Katowice
Katowice, , Poland
Vita Longa Sp. Z o.o.
Katowice, , Poland
MICS Centrum Medyczne Szczecin
Szczecin, , Poland
MTZ Clinical Research Powered by Pratia
Warsaw, , Poland
Premium Clinic Wrocław
Wroclaw, , Poland
Centrum Medyczne OPOROW
Wroclaw, , Poland
Centrum Leczenia Bolu dr n med Lukasz Kmieciak
Lodz, Łódź Voivodeship, Poland
Hospital Universitario de Elda
Elda, Alicante, Spain
Hospital Clinic de Barcelona Plato Headquarters
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Universitario Ruber Juan Bravo
Salamanca, , Spain
University Hospital Marqués de Valdecilla
Santander, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Virgen del Rocio University Hospital
Seville, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Consorcio Hospital General Universitario
Valencia, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
CTC Solna
Solna, Stockholms LÄN [se-01], Sweden
CTC MTC
Uppsala, Uppsala LÄN [se-03], Sweden
Carlanderska Hospital
Gothenburg, , Sweden
Skåneuro Privatmottagning
Lund, , Sweden
Hälsoklustret
Stockholm, , Sweden
Akardo Med Site
Stockholm, , Sweden
University Hospital Uppsala (VO Neuro)
Uppsala, , Sweden
Re: Cognition Health Ltd.
Edgebaston, Birmingham, United Kingdom
Hull University Hospitals NHS Trust
Hull, EAST Riding, United Kingdom
4 Medical Clinical Solutions London
Ilford, Essex, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, Norfolk, United Kingdom
Lakeside Healthcare Group Research
Corby, Northamptonshire, United Kingdom
Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom
Cognition Health - Bristol
Bristol, , United Kingdom
Kings College London
London, , United Kingdom
4 Medical Clinical Solutions
Swinton, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4951012
Identifier Type: OTHER
Identifier Source: secondary_id
BHV3000-407
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-001176-34
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-513270-21-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
BHV3000-407
Identifier Type: -
Identifier Source: org_study_id
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