Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
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
4 other identifiers
interventional
813
14 countries
91
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2022
Typical duration for phase_4
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2022
CompletedFirst Posted
Study publicly available on registry
August 22, 2022
CompletedStudy Start
First participant enrolled
October 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2025
CompletedResults Posted
Study results publicly available
April 21, 2026
CompletedApril 21, 2026
April 1, 2026
2.4 years
August 18, 2022
March 6, 2026
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Pain Relief at 2 Hours Post-Dose: DBT Phase
Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Pain relief at 2 hours post-dose was defined as pain intensity of none or mild at that time point.
At 2 hours post-dose
Secondary Outcomes (22)
Percentage of Participants With Pain Freedom at 2 Hours Post-Dose: DBT Phase
At 2 hours post-dose
Percentage of Participants Who Used Rescue Medications Within 24 Hours Post-Dose: DBT Phase
Within 24 hours post-dose
Percentage of Participants With Return to Normal Function at 2 Hours Post-Dose: DBT Phase
At 2 hours post-dose
Percentage of Participants With Sustained Return to Normal Function From 2 to 24 Hours Post-Dose: DBT Phase
From 2 to 24 hours post-dose
Percentage of Participants With Sustained Return to Normal Function From 2 to 48 Hours Post-Dose: DBT Phase
From 2 to 48 hours post-dose
- +17 more secondary outcomes
Study Arms (2)
Rimegepant
EXPERIMENTALRimegepant - 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)
Placebo
PLACEBO COMPARATORPlacebo - 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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (93)
Clinical Research Institute
Los Angeles, California, 90048, United States
Ki Health Partners LLC, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
Wr-Msra, Llc
Lake City, Florida, 32055, United States
Sensible Healthcare LLC
Ocoee, Florida, 34761, United States
Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit
Ormond Beach, Florida, 32174, United States
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328, United States
Collective Medical Research
Overland Park, Kansas, 66210, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Community Clinical Research Network Inc
Marlborough, Massachusetts, 01752, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Rochester Medical Group
Rochester Hills, Michigan, 48307, United States
DM Clinical Research - Detroit
Southfield, Michigan, 48076, United States
Clinvest Research, LLC
Springfield, Missouri, 65807, United States
St Charles Clinical Research
Weldon Spring, Missouri, 63304, United States
DM Clinical Research - NY, NY
Brooklyn, New York, 11220, United States
New York Neurology Associates
New York, New York, 10003, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Headache Wellness Center, PC
Greensboro, North Carolina, 27405, United States
Synexus Clinical Research US, Inc. - Anderson
Anderson, South Carolina, 29621, United States
Red Star Research, LLC
Lake Jackson, Texas, 77566, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
USC Clinical Trials Centre
Sippy Downs, Queensland, 4556, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Carinthia, 9020, Austria
Medical University Innsbruck
Innsbruck, Tyrol, 6020, Austria
Cabinet Privé Dr. Simona Sava
Saint-Nicolas, Liège, 4420, Belgium
GZA Ziekenhuizen
Antwerp, 2610, Belgium
UZ Brussel
Brussels, 1090, Belgium
UZ Gent
Ghent, 9000, Belgium
Jessa Ziekenhuis
Hasselt, 3500, Belgium
University of Calgary South Health Campus
Calgary, Alberta, T3M 1M4, Canada
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1, Canada
Clinique Neuro-Lévis
Lévis, Quebec, G6W 0M5, Canada
Alpha Recherche Clinique
Québec, Quebec, G3K 2P8, Canada
ALPHA Recherche Clinique
Québec, G2J 0C4, Canada
University Hospital of Southern Denmark
Esbjerg, DK-6700, Denmark
Danish Headache Center
Glostrup Municipality, 2600, Denmark
Hospitalsenhed Midt
Viborg, DK-8800, Denmark
Helsinki Headache Center
Helsinki, Uusimaa, 00830, Finland
Terveystalo Ruoholahti
Helsinki, Finland
Terveystalo Tampere Rautatienkatu
Tampere, 33100, Finland
Terveystalo Pulssi
Turku, 20100, Finland
Timone Hospital
Marseille, Provence, 13005, France
Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer
Bron, 69500, France
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, 63000, France
Centre Hospitalier Annecy Genevois
Epagny Metz-Tessy, 74370, France
CHU de Lille - Hôpital Salengro
Lille, 59037, France
CHU Nice Hopital Cimiez
Nice, 06000, France
Hopital Lariboisiere
Paris, 75010, France
CHU Saint-Etienne - Hopital Nord
Saint-Etienne, 42055, France
Neurologische Praxis Prof. Dr. Hartmut Gobel
Kiel, Schleswig-Holstein, D-24149, Germany
University Hospital Jena
Jena, Thuringia, 07747, Germany
Charité Universitätsmedizin Berlin, Neurologische Ambulanz, Kopfschmerzambulanz
Berlin, 10117, Germany
Kopfschmerzzentrum Frankfurt
Frankfurt, 65929, Germany
IRCCS Ospedale San Raffaele
Milan, MI, 20132, Italy
AOU Luigi Vanvitelli
Naples, Naples, 80138, Italy
Fondazione Policlinico Campus BioMedico
Rome, RM, 00128, Italy
Foundation IRCCS Neurological Institute Carlo Besta
Milan, 20133, Italy
AOU Policlinico di Modena
Modena, 41124, Italy
Fondazione Mondino - Istituto Neurologico Nazionale IRCCS
Pavia, 27100, Italy
Headache and Pain Unit - IRCCS San Raffaele
Rome, 00163, Italy
Clinical Research Institute S.C.
Tlalnepantla, State of Mexico, 54055, Mexico
Centro de Investigación Médica de Aguascalientes (CIMA)
Aguascalientes, 20116, Mexico
Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv
Mexico City, 14050, Mexico
Clinstile SA de CV
Mexico City, CDMX 06700, Mexico
Centrum Medyczne Neuromed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
Concept Medica
Warsaw, Masovian Voivodeship, 00-773, Poland
MICS Centrum Medyczne Damiana Walbrzyska
Warsaw, Masovian Voivodeship, 02-739, Poland
Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Oświęcim, Małopolska, 32-600, Poland
Vita Longa Sp. Z o.o.
Katowice, 40-748, Poland
MICS Centrum Medyczne Szczecin
Szczecin, 70-784, Poland
Praktyka Lekarska
Warsaw, 00-144, Poland
MTZ Clinical Research Powered by Pratia
Warsaw, 02-172, Poland
Centrum Leczenia Bolu dr n med Lukasz Kmieciak
Lodz, Łódź Voivodeship, 91-363, Poland
University Hospital Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Virgen del Rocio University Hospital
Seville, 41013, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
CTC Solna
Solna, Stockholms LÄN [se-01], 171 64, Sweden
CTC Uppsala
Uppsala, Uppsala County, 752 37, Sweden
Skåneuro Privatmottagning
Lund, 222 22, Sweden
Hälsoklustret
Stockholm, 112 39, Sweden
Akardo MedSite
Stockholm, 117 27, Sweden
Re: Cognition Health Ltd.
Edgebaston, Birmingham, B16 8LT, United Kingdom
4 Medical Clinical Solutions London
Ilford, Essex, IG1 4HP, United Kingdom
Lakeside Healthcare Group Research
Corby, Northamptonshire, NN17 2UR, United Kingdom
Kings College London
London, WC2R 2LS, United Kingdom
4 Medical Clinical Solutions
Swinton, M27 8FF, United Kingdom
Related Publications (2)
Ashina M, McAllister P, Gaul C, Leyva-Rendon A, Ramirez LM, Nalpas C, Thiry A, Abraham L, Fountaine RJ, Fullerton T. Can rimegepant stop symptoms of a migraine attack in people who have not found triptans to work well or are not recommended to use triptans? A plain language summary of a clinical study. Pain Manag. 2026 Apr 3:1-15. doi: 10.1080/17581869.2026.2646705. Online ahead of print.
PMID: 41930741DERIVEDAshina M, McAllister P, Gaul C, Leyva-Rendon A, Ramirez LM, Nalpas C, Thiry A, Abraham L, Fountaine RJ, Fullerton T. Rimegepant for acute treatment of migraine in triptan-unsuitable adults: A randomized, double-blind, placebo-controlled phase 4 trial. Cephalalgia. 2025 Nov;45(11):3331024251395298. doi: 10.1177/03331024251395298. Epub 2025 Nov 18.
PMID: 41255093DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2022
First Posted
August 22, 2022
Study Start
October 18, 2022
Primary Completion
March 10, 2025
Study Completion
June 10, 2025
Last Updated
April 21, 2026
Results First Posted
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.