Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
- Registration Number
- NCT05509400
- Lead Sponsor
- Pfizer
- Brief 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).
- Detailed Description
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). Rimegepant will be further evaluated in this population with as needed use in a 12-week, open-label extension study.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 633
- Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
- Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
- 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).
- Less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase.
- Subjects must be able to distinguish migraine attacks from tension/cluster headaches.
- Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study.
- Triptan unsuitable
-Target Disease Exclusion:
- History of cluster headache, basilar migraine, or hemiplegic migraine
- Current medication overuse headaches
- Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit
- Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS])
- 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
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo - Double-blind (DB) Phase: One dose of matching placebo Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine Placebo Rimegepant Placebo - Double-blind (DB) Phase: One dose of matching placebo Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine Rimegepant Rimegepant Rimegepant - Double-blind (DB) Phase: One dose of rimegepant 75 mg Oral Disintegrating Tablet (ODT) Rimegepant/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT as needed for a qualifying acute migraine. A qualifying migraine is an attack of moderate or severe headache pain intensity. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe)
- Primary Outcome Measures
Name Time Method Compare the efficacy of rimegepant with placebo in the acute treatment of migraine, as measured by migraine headache pain relief at 2-hours post-dose during the Double-Blind Treatment (DBT) Phase. 2 hours post-dose Migraine headache pain relief will be assessed using the percentage of subjects with a headache pain intensity of none or mild. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (93)
Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
4 Medical Clinical Solutions
🇬🇧Swinton, United Kingdom
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
IRCCS Ospedale San Raffaele
🇮🇹Milano, MI, Italy
AOU Luigi Vanvitelli
🇮🇹Napoli, Naples, Italy
Akardo MedSite
🇸🇪Stockholm, Sweden
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
Montefiore Medical Center
🇺🇸Bronx, New York, United States
DM Clinical Research - NY, NY
🇺🇸Brooklyn, New York, United States
New York Neurology Associates
🇺🇸New York, 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
Klinikum Klagenfurt am Wörthersee
🇦🇹Klagenfurt am Wörthersee, Carinthia, Austria
Medical University Innsbruck
🇦🇹Innsbruck, Tirol, Austria
Cabinet Privé Dr. Simona Sava
🇧🇪Saint Nicolas, Liège, Belgium
GZA Ziekenhuizen
🇧🇪Antwerpen, Belgium
UZ Brussel
🇧🇪Brussels, Belgium
UZ Gent
🇧🇪Gent, Belgium
University of Calgary South Health Campus
🇨🇦Calgary, Alberta, Canada
Aggarwal and Associates Limited
🇨🇦Brampton, Ontario, Canada
Clinique Neuro-Lévis
🇨🇦Levis, Quebec, Canada
ALPHA Recherche Clinique
🇨🇦Quebec, Canada
Alpha Recherche Clinique
🇨🇦Quebec, Canada
University Hospital of Southern Denmark
🇩🇰Esbjerg, Denmark
Danish Headache Center
🇩🇰Glostrup, 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 Cedex 2, France
Neurologische Praxis Prof. Dr. Hartmut Gobel
🇩🇪Kiel, Schleswig-holstein, Germany
University Hospital Jena
🇩🇪Jena, Thüringen, Germany
Charité Universitätsmedizin Berlin, Neurologische Ambulanz, Kopfschmerzambulanz
🇩🇪Berlin, Germany
Kopfschmerzzentrum Frankfurt
🇩🇪Frankfurt, Germany
Fondazione Policlinico Campus BioMedico
🇮🇹Rome, RM, Italy
Foundation IRCCS Neurological Institute Carlo Besta
🇮🇹Milano, Italy
University Modena e Reggio Emilia
🇮🇹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 de Baz, Estado DE Mexico, 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
Concept Medica
🇵🇱Warszawa, Mazowieckie, Poland
MICS Centrum Medyczne Damiana Walbrzyska
🇵🇱Warszawa, Mazowieckie, 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
🇵🇱Warszawa, Poland
MTZ Clinical Research Powered by Pratia
🇵🇱Warszawa, Poland
Centrum Leczenia Bolu dr n med Lukasz Kmieciak
🇵🇱Łódź, Łódzkie, 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
🇪🇸Sevilla, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
CTC Solna
🇸🇪Solna, Stockholms LÄN [se-01], Sweden
CTC Uppsala
🇸🇪Uppsala, Uppsala LÄN, Sweden
Skåneuro Privatmottagning
🇸🇪Lund, Sweden
Hälsoklustret
🇸🇪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