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Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
Sponsor: Pfizer
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
Rimegepant
DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT)
Placebo
DB Phase: matching placebo
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