A Phase 4, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With a History of Inadequate Response to Oral Preventive Medications

Status: Completed
Location: See all (111) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 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.

• 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).

Locations
United States
California
Clinical Research Institute
Los Angeles
California Neuroscience Research, LLC
Sherman Oaks
Connecticut
Ki Health Partners LLC, dba New England Institute for Clinical Research
Stamford
Florida
Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit
Edgewater
Wr-Msra,Llc
Lake City
AppleMed Research Group, LLC
Miami
Sensible Healthcare LLC
Ocoee
Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit
Ormond Beach
Massachusetts
Boston Clinical Trials
Boston
Community Clinical Research Network, Inc.
Marlborough
Michigan
Michigan Headache & Neurological Institute
Ann Arbor
Rochester Medical Group
Rochester Hills
Missouri
Clinvest Research, LLC
Springfield
St Charles Clinical Research
Weldon Spring
North Carolina
Headache Wellness Center, PC
Greensboro
New Mexico
Albuquerque Clinical Trials. Inc.
Albuquerque
Nevada
Wr-Crcn, Llc
Las Vegas
New York
DiGiovanna Institute for Medical Education And Research
North Massapequa
South Carolina
Synexus Clinical Research US, Inc. - Anderson
Anderson
Tennessee
Alliance for Multispecialty Reseach, LLC
Knoxville
Texas
Red Star Research, LLC
Lake Jackson
DM Clinical Research
Tomball
Washington
Northwest Clinical Research Center
Bellevue
Other Locations
Australia
USC Clinical Trials Sunshine Coast
Sippy Downs
Austria
Medical University Innsbruck
Innsbruck
Klinikum Klagenfurt am Wörthersee
Klagenfurt
Belgium
GZA Ziekenhuizen
Antwerp
AZ Sint-Jan Brugge-Oostende AV
Bruges
Jessa Ziekenhuis
Hasselt
UZ Brussel
Jette
Clinique de la Citadelle
Liège
Cabinet Privé Dr. Simona Sava
Saint Nicolas Province De Liège
Canada
Aggarwal and Associates Limited
Brampton
NeuPath Centre for Pain and Spine
Brampton
Centre de Recherche Saint-Louis/Clinique Neuro-Levis
Lévis
ALPHA Recherche Clinique
Québec
ALPHA Recherche Clinique
Québec
Denmark
Bispebjerg Hospital
Copenhagen Nv
University Hospital of Southern Denmark
Esbjerg
Danish Headache Center
Glostrup Municipality
Hospitalsenhed Midt
Viborg
Finland
Terveystalo Ruoholahti
Helsinki
Terveystalo Tampere
Tampere
Terveystalo Pulssi
Turku
Germany
Zentrum für klinische Forschung
Bad Homburg
Synexus - Prüfzentrum Berlin
Berlin
Kopfschmerzzentrum Frankfurt
Frankfurt Am Main
Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre
Frankfurt Am Main
Schmerz- und Palliativzentrum Göppingen
Göppingen
Synexus - Prüfzentrum Leipzig
Leipzig
Neuropoint GmbH
Ulm Baden-wuerttemberg
Studienzentrum Nordwest
Westerstede
Intermed GmbH
Wiesbaden
Italy
SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
Florence
IRCCS Fondazione Besta
Milan
IRCCS Ospedale San Raffaele
Milan
University Modena e Reggio Emilia
Modena
AOU Luigi Vanvitelli
Napoli
IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino
Pavia
IRCCS San Raffaele
Rome
Mexico
Centro de Investigación Médica de Aguascalientes (CIMA)
Aguascalientes
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli
Medical Care and Research S.A. de C.V.
Mérida
Clinstile, SA de CV
Mexico City
Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv
Mexico City
Clinical Research Institute S.C.
Tlalnepantla
Poland
Centrum Medyczne Neuromed
Bydgoszcz
Centrum Medyczne Pratia Katowice
Katowice
Vita Longa Sp. Z o.o.
Katowice
Centermed Kraków Sp. Z o.o.
Krakow
Centrum Leczenia Bolu dr n med Lukasz Kmieciak
Lodz
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól
Instytut Zdrowia
Oświęcim
MICS Centrum Medyczne Szczecin
Szczecin
Concept Medica
Warsaw
Dr Sekowska Leczenie Bolu
Warsaw
MICS Centrum Medyczne Damiana Walbrzyska
Warsaw
MTZ Clinical Research Powered by Pratia
Warsaw
Centrum Medyczne OPOROW
Wroclaw
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw
Premium Clinic Wrocław
Wroclaw
Spain
Hospital Clinic de Barcelona Plato Headquarters
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Universitario de Elda
Elda
Hospital Universitario de La Princesa
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Hospital Universitario HM Sanchinarro
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Ruber Juan Bravo
Salamanca
University Hospital Marqués de Valdecilla
Santander
Hospital Universitario Virgen Macarena
Seville
Virgen del Rocio University Hospital
Seville
Consorcio Hospital General Universitario
Valencia
Hospital Clínico Universitario de Valencia
Valencia
Hospital Clinico Universitario de Valladolid
Valladolid
Sweden
Carlanderska Hospital
Gothenburg
Skåneuro Privatmottagning
Lund
CTC Solna
Solna
Akardo Med Site
Stockholm
Hälsoklustret
Stockholm
CTC MTC
Uppsala
University Hospital Uppsala (VO Neuro)
Uppsala
United Kingdom
Cognition Health - Bristol
Bristol
Lakeside Healthcare Group Research
Corby
Re: Cognition Health Ltd.
Edgebaston
Queen Elizabeth University Hospital
Glasgow
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth
Hull University Hospitals NHS Trust
Hull
4 Medical Clinical Solutions London
Ilford
Kings College London
London
4 Medical Clinical Solutions
Swinton
Time Frame
Start Date: 2022-11-07
Completion Date: 2025-07-08
Participants
Target number of participants: 658
Treatments
Experimental: Rimegepant 75 mg
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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