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

Phase 4

Active, not recruiting

• Conditions: Migraine
• Interventions: Drug: Rimegepant; Drug: Placebo

• Registration Number: NCT05518123
• Lead Sponsor: Pfizer

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2022-11-07
• Primary Completion: 2025-03-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Study Completion: 2025-07-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 659

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rimegepant 75 mg	Rimegepant	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Compare the efficacy of rimegepant (75 mg) to placebo	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.

Trial Locations

Locations (110)

University Hospital Uppsala (VO Neuro); 🇸🇪 Uppsala, Sweden

GZA Ziekenhuizen; 🇧🇪 Antwerpen, Belgium

AZ Sint-Jan Brugge-Oostende AV; 🇧🇪 Brugge, 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

Consorcio Hospital General Universitario; 🇪🇸 Valencia, Spain

Hospitalsenhed Midt; 🇩🇰 Viborg, Denmark

Akardo Med Site; 🇸🇪 Stockholm, Sweden

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, Tirol, Austria

Klinikum Klagenfurt am Wörthersee; 🇦🇹 Klagenfurt am Wörthersee, Austria

UZ Brussel; 🇧🇪 Jette, Brussels, Belgium

NeuPath Centre for Pain and Spine; 🇨🇦 Brampton, Ontario, Canada

Centre de Recherche Saint-Louis/Clinique Neuro-Levis; 🇨🇦 Levis, Quebec, Canada

ALPHA Recherche Clinique; 🇨🇦 Quebec, Canada

Bispebjerg Hospital; 🇩🇰 Copenhagen NV, Capital Region, Denmark

Danish Headache Center; 🇩🇰 Glostrup, Region Hovedstaden, Denmark

University Hospital of Southern Denmark; 🇩🇰 Esbjerg, Denmark

Terveystalo Ruoholahti; 🇫🇮 Helsinki, Uusimaa, Finland

Terveystalo Tampere; 🇫🇮 Tampere, Finland

Terveystalo Pulssi; 🇫🇮 Turku, Finland

Schmerz- und Palliativzentrum Göppingen; 🇩🇪 Göppingen, Baden-wuerttemberg, Germany

Zentrum für klinische Forschung; 🇩🇪 Bad Homburg, Hessen, Germany

Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre; 🇩🇪 Frankfurt am Main, Hessen, Germany

Kopfschmerzzentrum Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany

Intermed GmbH; 🇩🇪 Wiesbaden, Hessen, Germany

Studienzentrum Nordwest; 🇩🇪 Westerstede, Niedersachsen, Germany

Synexus - Prüfzentrum Leipzig; 🇩🇪 Leipzig, Sachsen, Germany

Synexus - Prüfzentrum Berlin; 🇩🇪 Berlin, Germany

Neuropoint GmbH; 🇩🇪 Ulm Baden-Wuerttemberg, Germany

IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino; 🇮🇹 Pavia, Lombardia, Italy

IRCCS Ospedale San Raffaele; 🇮🇹 Milano, 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.; 🇲🇽 Cuautitlan Izcalli, Estado DE Mexico, Mexico

Clinical Research Institute S.C.; 🇲🇽 Tlalnepantla de Baz, Estado DE Mexico, Mexico

Medical Care and Research S.A. de C.V.; 🇲🇽 Merida, Yucatan, Mexico

Centro de Investigación Médica de Aguascalientes (CIMA); 🇲🇽 Aguascalientes, Mexico

Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv; 🇲🇽 Ciudad de México, Mexico

Clinstile, SA de CV; 🇲🇽 Mexico City, Mexico

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak; 🇵🇱 Wroclaw, Dolnoslaskie, Poland

Centrum Medyczne Neuromed; 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Twoja Przychodnia Nowosolskie Centrum Medyczne; 🇵🇱 Nowa Sol, Lubuskie, Poland

Centermed Kraków Sp. Z o.o.; 🇵🇱 Krakow, Malopolska, Poland

Concept Medica; 🇵🇱 Warszawa, Mazowieckie, Poland

Dr Sekowska Leczenie Bolu; 🇵🇱 Warszawa, Mazowieckie, Poland

MICS Centrum Medyczne Damiana Walbrzyska; 🇵🇱 Warszawa, Mazowieckie, 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; 🇵🇱 Warszawa, Poland

Premium Clinic Wrocław; 🇵🇱 Wroclaw, Poland

Centrum Medyczne OPOROW; 🇵🇱 Wroclaw, Poland

Centrum Leczenia Bolu dr n med Lukasz Kmieciak; 🇵🇱 Łódź, Łódzkie, 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; 🇪🇸 Sevilla, Spain

Virgen del Rocio University Hospital; 🇪🇸 Sevilla, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 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; 🇸🇪 Goteborg, Sweden

Skåneuro Privatmottagning; 🇸🇪 Lund, Sweden

Hälsoklustret; 🇸🇪 Stockholm, 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