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NCT05509400CompletedPhase 4

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

Source: ClinicalTrials.gov · Last updated 21 Apr 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
813 (actual)
First submitted
18 Aug 2022
Start date
18 Oct 2022
Primary completion date
10 Mar 2025
Lead sponsor
Pfizer
Diseases
Migraine
NCT number
NCT05509400
EU CT number
2024-513269-37-00
EudraCT number
2022-001175-14

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 813
  • From 18 Oct 2022 to the primary completion date, 10 Mar 2025
  • 99 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • -Target Disease Exclusion:
  • History of cluster headache, basilar migraine, or hemiplegic migraine
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (99)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaCompleted
Klinikum Klagenfurt am Wörthersee
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Klagenfurt am WörtherseeAustriaCompleted
Medical University of Vienna
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ViennaAustriaCompleted
Alfred Hospital
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MelbourneAustraliaUnknown status
USC Clinical Trials Centre
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Sippy DownsAustraliaUnknown status
GasthuisZusters Antwerpen
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AntwerpBelgiumCompleted
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
JESSA Ziekenhuis
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HasseltBelgiumCompleted
UZ Brussel
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JetteBelgiumCompleted
Céphalées et Migraines Neurologie Générale EMG Electromyographie EEG Electroencéphalographie
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Saint NicolasBelgiumCompleted
Aggarwal and Associates Limited
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BramptonCanadaUnknown status
University of Calgary South Health Campus
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CalgaryCanadaUnknown status
Clinique Neuro-Lévis
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LévisCanadaUnknown status
Alpha Recherche Clinique
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QuébecCanadaUnknown status
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Kopfschmerzzentrum Frankfurt
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Frankfurt a. M.GermanyCompleted
Universitaetsmedizin Greifswald KöR
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GreifswaldGermanyCompleted
Universitaetsklinikum Jena KöR
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JenaGermanyCompleted
Vitos Orthopaedische Klinik Kassel gGmbH
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KasselGermanyCompleted
Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie
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KielGermanyCompleted
DKD HELIOS Klinik Wiesbaden GmbH
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WiesbadenGermanyCompleted
Bispebjerg Hospital
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Copenhagen NvDenmarkCompleted
Esbjerg Og Grindsted Sygehus
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EsbjergDenmarkCompleted
Rigshospitalet
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GlostrupDenmarkCompleted
Regionshospitalet Viborg
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ViborgDenmarkCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Ruber Juan Bravo
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainCompleted
Suomen Terveystalo Oy
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HelsinkiFinlandCompleted
Suomen Terveystalo Oy
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TampereFinlandCompleted
Suomen Terveystalo Oy
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TurkuFinlandCompleted
Hospices Civils de Lyon
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BronFranceCompleted
University Hospital Of Clermont-Ferrand
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Clermont Ferrand Cedex 1FranceCompleted
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceCompleted
Timone University Hospital
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MarseilleFranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Centre Hospitalier Annecy Genevois
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Pringy CedexFranceCompleted
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceCompleted
Lakeside Healthcare Group Research
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CorbyUnited KingdomUnknown status
Re: Cognition Health Ltd.
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EdgebastonUnited KingdomUnknown status
4 Medical Clinical Solutions London
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IlfordUnited KingdomUnknown status
Kings College London
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LondonUnited KingdomUnknown status
4 Medical Clinical Solutions
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SwintonUnited KingdomUnknown status
Policlinico di Bari
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BariItalyCompleted
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
Policlinico di Modena
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ModenaItalyCompleted
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyCompleted
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
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PaviaItalyCompleted
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyCompleted
Irccs San Raffaele Roma S.r.l.
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RomeItalyCompleted
Centro de Investigación Médica de Aguascalientes (CIMA)
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AguascalientesMexicoUnknown status
Clinstile SA de CV
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Mexico CityMexicoUnknown status
Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv
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Mexico CityMexicoUnknown status
Clinical Research Institute S.C.
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TlalnepantlaMexicoUnknown status
Centrum Medyczne Neuromed Sp. z.o.o.
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BydgoszczPolandCompleted
Vita Longa Sp. Z o.o.
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KatowicePolandCompleted
Headache Management Centre Dr Lukasz Kmieciak
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ŁódźPolandCompleted
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
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Nowa SolPolandCompleted
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
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OswiecimPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
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SzczecinPolandCompleted
Centrum Medyczne Damiana Holding Sp. z o.o.
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WarsawPolandCompleted
MTZ Clinical Research powered by Pratia
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WarsawPolandCompleted
Clinirem Sp. z o.o.
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WarsawPolandCompleted
Dr Sekowska Leczenie Bolu
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WarszawaPolandCompleted
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
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WroclawPolandCompleted
Skaneuro AB
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LundSwedenCompleted
CTC Clinical Trial Consultants AB
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SolnaSwedenCompleted
Akardo AB
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StockholmSwedenCompleted
Halsoklustret AB
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StockholmSwedenCompleted
CTC Clinical Trial Consultants AB
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UppsalaSwedenCompleted
Synexus Clinical Research US, Inc. - Anderson
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AndersonUnited StatesUnknown status
Michigan Headache & Neurological Institute
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Ann ArborUnited StatesUnknown status
Northwest Clinical Research Center
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BellevueUnited StatesUnknown status
Boston Clinical Trials
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BostonUnited StatesUnknown status
DM Clinical Research - NY, NY
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BrooklynUnited StatesUnknown status
Headache Wellness Center, PC
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GreensboroUnited StatesUnknown status
Wr-Msra,Llc
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Lake CityUnited StatesUnknown status
Red Star Research, LLC
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Lake JacksonUnited StatesUnknown status
Clinical Research Institute
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Los AngelesUnited StatesUnknown status
Community Clinical Research Network, Inc.
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MarlboroughUnited StatesUnknown status
Delricht Research
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New OrleansUnited StatesUnknown status
New York Neurology Associates
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New YorkUnited StatesUnknown status
Sensible Healthcare, LLC
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OcoeeUnited StatesUnknown status
Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit
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Ormond BeachUnited StatesUnknown status
Collective Medical Research
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Overland ParkUnited StatesUnknown status
Rochester Medical Group
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Rochester HillsUnited StatesUnknown status
WR-Mount Vernon Clinical Research, LLC
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Sandy SpringsUnited StatesUnknown status
DM Clinical Research - Detroit
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SouthfieldUnited StatesUnknown status
Clinvest Research, LLC
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SpringfieldUnited StatesUnknown status
Ki Health Partners, LLc, dba New England Institute for Clinical Research
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StamfordUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
DM Clinical Research
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TomballUnited StatesUnknown status
St. Charles Clinical Research
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Weldon SpringUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.