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COMPLETED
NCT05509400
PHASE4

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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).

Official title: BHV3000-406 (C4951004): A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

813

Start Date

2022-10-18

Completion Date

2025-06-10

Last Updated

2026-04-21

Healthy Volunteers

No

Conditions

Interventions

DRUG

Rimegepant

DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT)

DRUG

Placebo

DB Phase: matching placebo

DRUG

Rimegepant

OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines

Locations (93)

Clinical Research Institute

Los Angeles, California, United States

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

Stamford, Connecticut, United States

Wr-Msra, Llc

Lake City, 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

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, United States

Collective Medical Research

Overland Park, Kansas, United States

DelRicht Research

New Orleans, Louisiana, 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

DM Clinical Research - Detroit

Southfield, Michigan, United States

Clinvest Research, LLC

Springfield, Missouri, United States

St Charles Clinical Research

Weldon Spring, Missouri, United States

DM Clinical Research - NY, NY

Brooklyn, New York, United States

New York Neurology Associates

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Headache Wellness Center, PC

Greensboro, North Carolina, United States

Synexus Clinical Research US, Inc. - Anderson

Anderson, South Carolina, 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 Centre

Sippy Downs, Queensland, Australia

Alfred Hospital

Melbourne, Victoria, Australia

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Carinthia, Austria

Medical University Innsbruck

Innsbruck, Tyrol, Austria

Cabinet Privé Dr. Simona Sava

Saint-Nicolas, Liège, Belgium

GZA Ziekenhuizen

Antwerp, Belgium

UZ Brussel

Brussels, Belgium

UZ Gent

Ghent, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

University of Calgary South Health Campus

Calgary, Alberta, Canada

Aggarwal and Associates Limited

Brampton, Ontario, Canada

Clinique Neuro-Lévis

Lévis, Quebec, Canada

Alpha Recherche Clinique

Québec, Quebec, Canada

ALPHA Recherche Clinique

Québec, Canada

University Hospital of Southern Denmark

Esbjerg, Denmark

Danish Headache Center

Glostrup Municipality, Denmark

Hospitalsenhed Midt

Viborg, Denmark

Helsinki Headache Center

Helsinki, Uusimaa, Finland

Terveystalo Ruoholahti

Helsinki, Finland

Terveystalo Tampere Rautatienkatu

Tampere, Finland

Terveystalo Pulssi

Turku, Finland

Timone Hospital

Marseille, Provence, France

Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer

Bron, France

CHU Clermont Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, France

Centre Hospitalier Annecy Genevois

Epagny Metz-Tessy, France

CHU de Lille - Hôpital Salengro

Lille, France

CHU Nice Hopital Cimiez

Nice, France

Hopital Lariboisiere

Paris, France

CHU Saint-Etienne - Hopital Nord

Saint-Etienne, France

Neurologische Praxis Prof. Dr. Hartmut Gobel

Kiel, Schleswig-Holstein, Germany

University Hospital Jena

Jena, Thuringia, Germany

Charité Universitätsmedizin Berlin, Neurologische Ambulanz, Kopfschmerzambulanz

Berlin, Germany

Kopfschmerzzentrum Frankfurt

Frankfurt, Germany

IRCCS Ospedale San Raffaele

Milan, MI, Italy

AOU Luigi Vanvitelli

Naples, Naples, Italy

Fondazione Policlinico Campus BioMedico

Rome, RM, Italy

Foundation IRCCS Neurological Institute Carlo Besta

Milan, Italy

AOU Policlinico di Modena

Modena, Italy

Fondazione Mondino - Istituto Neurologico Nazionale IRCCS

Pavia, Italy

Headache and Pain Unit - IRCCS San Raffaele

Rome, Italy

Clinical Research Institute S.C.

Tlalnepantla, State of Mexico, Mexico

Centro de Investigación Médica de Aguascalientes (CIMA)

Aguascalientes, Mexico

Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv

Mexico City, Mexico

Clinstile 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

Concept Medica

Warsaw, Masovian Voivodeship, Poland

MICS Centrum Medyczne Damiana Walbrzyska

Warsaw, Masovian Voivodeship, Poland

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

Oświęcim, Małopolska, Poland

Vita Longa Sp. Z o.o.

Katowice, Poland

MICS Centrum Medyczne Szczecin

Szczecin, Poland

Praktyka Lekarska

Warsaw, Poland

MTZ Clinical Research Powered by Pratia

Warsaw, Poland

Centrum Leczenia Bolu dr n med Lukasz Kmieciak

Lodz, Łódź Voivodeship, Poland

University Hospital Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario La Paz

Madrid, Spain

Virgen del Rocio University Hospital

Seville, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

CTC Solna

Solna, Stockholms LÄN [se-01], Sweden

CTC Uppsala

Uppsala, Uppsala County, Sweden

Skåneuro Privatmottagning

Lund, Sweden

Hälsoklustret

Stockholm, Sweden

Akardo MedSite

Stockholm, Sweden

Re: Cognition Health Ltd.

Edgebaston, Birmingham, United Kingdom

4 Medical Clinical Solutions London

Ilford, Essex, United Kingdom

Lakeside Healthcare Group Research

Corby, Northamptonshire, United Kingdom

Kings College London

London, United Kingdom

4 Medical Clinical Solutions

Swinton, United Kingdom