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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05518123
Other study ID # BHV3000-407
Secondary ID C4951012BHV3000-
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 7, 2022
Est. completion date February 11, 2025

Study information

Verified date June 2024
Source Pfizer
Contact Pfizer Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date February 11, 2025
Est. primary completion date February 11, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age. 2. Migraine attacks, on average, lasting about 4 - 72 hours, if untreated. 3. 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). 4. Less than15 headache days (migraine or non-migraine) per month in each of the 3-months prior to the Screening Visit and throughout the Screening Phase. 5. Subjects must be able to distinguish migraine attacks from tension/cluster headaches. Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered, migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication). Exclusion Criteria: 1. History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine. 2. Current medication overuse headaches. 3. 15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the 28- day Observation Phase. 4. Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across > 4 categories of recognized, orally administered, migraine-preventive medications. 5. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS]). 6. 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


Related Conditions & MeSH terms


Intervention

Drug:
Rimegepant
Rimegepant 75 mg Oral Disintegrating Tablet (ODT) taken every other day during Double-blind Treatment (DBT) phase
Placebo
Matching placebo with every other day dosing during DBT phase

Locations

Country Name City State
Australia Genesis Research Services Broadmeadow New South Wales
Australia Genesis Research Services Newcastle New South Wales
Australia USC Clinical Trials Sunshine Coast Sippy Downs Queensland
Australia PainMedSA & CerCare Pty Ltd Wayville South Australia
Austria Medical University Innsbruck Innsbruck Tirol
Austria Klinikum Klagenfurt am Wörthersee Klagenfurt am Wörthersee
Austria Medical University of Vienna Vienna
Austria Medical University of Vienna Vienna
Belgium GZA Ziekenhuizen Antwerpen
Belgium AZ Sint-Jan Brugge
Belgium AZ Sint-Jan Brugge-Oostende AV Brugge
Belgium UZ Brussel Brussel
Belgium Jessa Ziekenhuis Hasselt
Belgium UZ Brussel Jette Brussels
Belgium Clinique de la Citadelle Liège
Belgium Cabinet Privé Dr. Simona Sava Saint Nicolas Province De Liège
Canada NeuPath Centre for Pain and Spine Brampton Ontario
Canada Centre de Recherche Saint-Louis/Clinique Neuro-Levis Levis Quebec
Canada Clinique Neuro-Lévis Levis Quebec
Canada Alpha Recherche Clinique Quebec
Canada ALPHA Recherche Clinique Quebec
Canada Diex Recherche Sherbrooke Inc. Sherbrooke Quebec
Denmark Bispebjerg Hospital Copenhagen
Denmark Bispebjerg Hospital Copenhagen NV Capital Region
Denmark Danish Headache Center Glostrup Region Hovedstaden
Denmark Hospitalsenhed Midt Viborg
Finland Terveystalo Oy Helsinki
Finland Terveystalo Ruoholahti Helsinki
Finland Terveystalo Ruoholahti Helsinki Uusimaa
Finland Terveystalo Tampere Tampere
Finland Terveystalo Pulssi Turku
Germany Zentrum für klinische Forschung Bad Homburg Hessen
Germany Zentrum für klinische Forschung Bad Homburg Hessen
Germany Neurozentrum Tempelhof Berlin Berlin
Germany Synexus - Prüfzentrum Berlin Berlin
Germany Studiumzentrum Dr. A. Schwittay Böhlen Sachsen
Germany Kopfschmerzzentrum Frankfurt Frankfurt
Germany Kopfschmerzzentrum Frankfurt Frankfurt Hessen
Germany Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre Frankfurt am Main Hessen
Germany Schmerz- und Palliativzentrum Göppingen Göppingen Baden-wuerttemberg
Germany Universitätsmedizin Greifswald Greifswald
Germany Universitätsmedizin Greifswald Greifswald Mecklenburg-vorpommern
Germany Synexus - Prüfzentrum Leipzig Leipzig Sachsen
Germany Neuropoint GmbH Ulm Baden-Wuerttemberg
Germany Studienzentrum Nordwest Westerstede
Germany Studienzentrum Nordwest Westerstede Niedersachsen
Germany Intermed GmbH Wiesbaden Hessen
Germany Intermed GmbH Wiesbaden Hessen
Italy SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi Florence
Italy IRCCS Fondazione Besta Milan
Italy IRCCS Ospedale San Raffaele Milano MI
Italy Ospedale San Raffaele Milano MI
Italy AOU Policlinico di Modena Modena, Emilia-Romagna Modena
Italy AOU Luigi Vanvitelli Napoli Naples
Italy AOU Luigi Vanvitelli Napoli Naples
Italy Fondazione Mondino - Istituto Neurologico Nazionale IRCCS Pavia
Italy IRCCS Fondazione Istituto Neurologico C. Mondino Pavia
Italy Clinical Trial Center IRCCS Mondino Pavia (PV) Pavia
Italy Fondazione Policlinico Campus BioMedico Rome RM
Italy IRCCS San Raffaele Rome Rome/lazio
Italy IRCCS San Raffaele Roma Rome
Mexico Centro de Investigación Médica de Aguascalientes (CIMA) Aguascalientes
Mexico Unidad de Investigación En Salud de Chihuahua Sc Alcadia Tlalpan Ciudad DE Mexico
Mexico Phylasis Clinicas Research S. de R.L. de C.V. Cuautitlan Izcalli Estado DE Mexico
Mexico Medical Care and Research S.A. de C.V. Merida Yucatan
Mexico Medical Care and Research S.A. de C.V. Merida Yucatan
Mexico Clinstile, SA de CV Mexico City
Mexico Unidad de Investigación En Salud de Chihuahua Sc Mexico City
Mexico Clinical Research Institute S.C. Tlalnepantla de Baz Estado DE Mexico
Mexico Clinical Research Institute S.C. Tlalnepantla de Baz Estado DE Mexico
Poland Centrum Medyczne Neuromed Bydgoszcz Kujawsko-pomorskie
Poland Centrum Medyczne Pratia Katowice Katowice
Poland Vita Longa Sp. Z o.o. Katowice
Poland Centermed Kraków Sp. Z o.o. Krakow Malopolska
Poland Centermed Kraków Sp. Z o.o. Kraków
Poland Centrum Leczenia Bolu dr n med Lukasz Kmieciak Lódz Lódzkie
Poland Twoja Przychodnia Nowosolskie Centrum Medyczne Nowa Sol Lubuskie
Poland Instytut Zdrowia Oswiecim Malopolska
Poland MICS Centrum Medyczne Szczecin Szczecin
Poland Concept Medica Warszawa Mazowieckie
Poland Dr Sekowska Leczenie Bolu Warszawa Mazowieckie
Poland Dr Sekowska Leczenie Bolu Warszawa
Poland MICS Centrum Medyczne Damiana Walbrzyska Warszawa Mazowieckie
Poland Praktyka Lekarska Warszawa
Poland Centrum Medyczne OPOROW Wroclaw
Poland Premium Clinic Wroclaw Wroclaw
Spain Hospital Clinic de Barcelona Plato Headquarters Barcelona
Spain Hospital Universitario Vall d'Hebron Barcelona
Spain Hospital Universitario de Elda Elda Alicante
Spain Hospital de la Princesa Madrid Madrid, Comunidad DE
Spain Hospital HM Sanchinarro Madrid
Spain Hospital Universitario de La Princesa Madrid
Spain Hospital Universitario Fundacion Jimenez Diaz Madrid
Spain Hospital Universitario HM Sanchinarro Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital HM Sanchinarro Sanchinarro Madrid, Comunidad DE
Spain University Hospital Marqués de Valdecilla Santander
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Virgen del Rocio University Hospital Sevilla
Spain Virgen del Rocio University Hospital Sevilla
Spain Consorcio Hospital General Universitario Valencia
Spain Consorcio Hospital General Universitario Valencia
Spain Hospital Clínico Universitario de Valencia Valencia
Spain Hospital General de Valencia Valencia València
Spain Hospital Clinico Universitario de Valladolid Valladolid
Spain Hospital Universitario de Valladolid Valladolid
Sweden Carlanderska Hospital Goteborg
Sweden Carlanderska Hospital Gothenburg
Sweden Skåneuro Privatmottagning Lund
Sweden CTC Solna Solna Stockholms LÄN [se-01]
Sweden Akardo Med Site Stockholm
Sweden Akardo Med Site Stockholm
Sweden Hälsoklustret Stockholm
Sweden CTC MTC Uppsala Uppsala LÄN [se-03]
Sweden CTC Uppsala Uppsala Uppsala LÄN [se-03]
Sweden CTC Uppsala Uppsala
Sweden University Hospital Uppsala (VO Neuro) Uppsala
United Kingdom Re:Cognition Health - Birmingham Birmingham
United Kingdom Cognition Health - Bristol Bristol
United Kingdom Cognition Health - Bristol Bristol
United Kingdom Lakeside Healthcare Group Research Corby Northamptonshire
United Kingdom Cognition Health - Birmingham Edgbaston Birmingham
United Kingdom Re: Cognition Health Ltd. Edgebaston Birmingham
United Kingdom James Paget University Hospital Great Yarmouth Norfolk
United Kingdom James Paget University Hospital Great Yarmouth Other
United Kingdom James Paget University Hospitals NHS Foundation Trust Great Yarmouth Norfolk
United Kingdom Hull University Hospitals NHS Trust Hull EAST Riding
United Kingdom Hull University Hospitals NHS Trust Hull EAST Riding
United Kingdom Hull University Hospitals NHS Trust Hull
United Kingdom The Walton Centre NHS Foundation Trust Liverpool
United Kingdom Kings College London London
United Kingdom The Oxford University Hospitals NHS Foundation Trust Oxford Oxfordshire
United Kingdom South Tyneside and Sunderland NHS Foundation Trust Sunderland, Tyne & Wear
United Kingdom 4 Medical Clinical Solutions Swinton, Manchester
United States Albuquerque Clinical Trials. Inc. Albuquerque New Mexico
United States Synexus Clinical Research US, Inc. - Anderson Anderson South Carolina
United States Michigan Headache & Neurological Institute Ann Arbor Michigan
United States Northwest Clinical Research Center Bellevue Washington
United States Boston Clinical Trials Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States DM Clinical Research - Brooklyn Brooklyn New York
United States DM Clinical Research - NY, NY Brooklyn New York
United States Complete Health Research Edgewater Florida
United States Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit Edgewater Florida
United States Headache Wellness Center, PC Greensboro North Carolina
United States Alliance for Multispecialty Reseach, LLC Knoxville Tennessee
United States Wr-Msra,Llc Lake City Florida
United States Red Star Research, LLC Lake Jackson Texas
United States Wr-Crcn, Llc Las Vegas Nevada
United States Community Clinical Research Network, Inc. Marlborough Massachusetts
United States AppleMed Research Group, LLC Miami Florida
United States DiGiovanna Institute for Medical Education And Research North Massapequa New York
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 Rochester Medical Group Rochester Hills Michigan
United States StudyMetrix Research Saint Peters Missouri
United States California Neuroscience Research, LLC Sherman Oaks California
United States DM Clinical Research - Detroit, MI Southfield Michigan
United States Clinvest Research, LLC Springfield Missouri
United States Clinvest Research, LLC Springfield Missouri
United States Ki Health Partners LLC, dba New England Institute for Clinical Research Stamford Connecticut
United States DM Clinical Research Tomball Texas
United States St Charles Clinical Research Weldon Spring Missouri

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  Finland,  Germany,  Italy,  Mexico,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare the efficacy of rimegepant (75 mg) to placebo Subjects are dosed every other day, for the preventative treatment of migraine as measured by mean change in number of migraine days per month (28 days) over 12 week DBT Phase. A migraine day is any calendar day in which the subject experiences a qualified migraine headache. This includes any calendar day in which the subject takes an acute migraine-specific medication. Week 1 to 12 of DBT Phase
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