Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
NCT ID: NCT05509400
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
632 participants
INTERVENTIONAL
2022-10-18
2025-06-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications
NCT05518123
Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults
NCT03732638
Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention
NCT05207865
A Real-world, Prospective Observational Study of Rimegepant ODT for the Acute Treatment of Migraine Attacks in Adults.
NCT06467370
Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)
NCT05399485
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
Rimegepant
DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT)
Rimegepant
OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines
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
DB Phase: matching placebo
Rimegepant
OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
1. History of cluster headache, basilar migraine, or hemiplegic migraine
2. Current medication overuse headaches
3. Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit
4. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \[CRPS\])
5. 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
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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-Alpes-Côte d'Azur Region, 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
Napoli, 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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C4951004
Identifier Type: OTHER
Identifier Source: secondary_id
2022-001175-14
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-513269-37-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
BHV3000-406
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.