Clinical trial NCT05518123: Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine Prevention
Headache
Headache Prevention
Migraine Prevention in adults with inadequate response to oral preventative medications
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 659
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: 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 first 28- days of the 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.

Primary outcomes:
measure: Compare the efficacy of rimegepant (75 mg) to placebo
timeFrame: Week 1 to 12 of DBT Phase
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical Research Institute
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research, LLC
state: California
city: Stamford
country: United States
facility: Ki Health Partners LLC, dba New England Institute for Clinical Research
state: Connecticut
city: Edgewater
country: United States
facility: Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit
state: Florida
city: Lake City
country: United States
facility: Wr-Msra,Llc
state: Florida
city: Miami
country: United States
facility: AppleMed Research Group, LLC
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare LLC
state: Florida
city: Ormond Beach
country: United States
facility: Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit
state: Florida
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Marlborough
country: United States
facility: Community Clinical Research Network, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute
state: Michigan
city: Rochester Hills
country: United States
facility: Rochester Medical Group
state: Michigan
city: Springfield
country: United States
facility: Clinvest Research, LLC
state: Missouri
city: Weldon Spring
country: United States
facility: St Charles Clinical Research
state: Missouri
city: Las Vegas
country: United States
facility: Wr-Crcn, Llc
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials. Inc.
state: New Mexico
city: North Massapequa
country: United States
facility: DiGiovanna Institute for Medical Education And Research
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center, PC
state: North Carolina
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc. - Anderson
state: South Carolina
city: Knoxville
country: United States
facility: Alliance for Multispecialty Reseach, LLC
state: Tennessee
city: Lake Jackson
country: United States
facility: Red Star Research, LLC
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Sippy Downs
country: Australia
facility: USC Clinical Trials Sunshine Coast
state: Queensland
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tirol
city: Klagenfurt am Wörthersee
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussels
city: Antwerpen
country: Belgium
facility: GZA Ziekenhuizen
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Liège
country: Belgium
facility: Clinique de la Citadelle
city: Saint Nicolas Province De Liège
country: Belgium
facility: Cabinet Privé Dr. Simona Sava
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: Brampton
country: Canada
facility: NeuPath Centre for Pain and Spine
state: Ontario
city: Levis
country: Canada
facility: Centre de Recherche Saint-Louis/Clinique Neuro-Levis
state: Quebec
city: Quebec
country: Canada
facility: ALPHA Recherche Clinique
city: Quebec
country: Canada
facility: ALPHA Recherche Clinique
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
state: Capital Region
city: Glostrup
country: Denmark
facility: Danish Headache Center
state: Region Hovedstaden
city: Esbjerg
country: Denmark
facility: University Hospital of Southern Denmark
city: Viborg
country: Denmark
facility: Hospitalsenhed Midt
city: Helsinki
country: Finland
facility: Terveystalo Ruoholahti
state: Uusimaa
city: Tampere
country: Finland
facility: Terveystalo Tampere
city: Turku
country: Finland
facility: Terveystalo Pulssi
city: Göppingen
country: Germany
facility: Schmerz- und Palliativzentrum Göppingen
state: Baden-wuerttemberg
city: Bad Homburg
country: Germany
facility: Zentrum für klinische Forschung
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre
state: Hessen
city: Frankfurt
country: Germany
facility: Kopfschmerzzentrum Frankfurt
state: Hessen
city: Wiesbaden
country: Germany
facility: Intermed GmbH
state: Hessen
city: Westerstede
country: Germany
facility: Studienzentrum Nordwest
state: Niedersachsen
city: Leipzig
country: Germany
facility: Synexus - Prüfzentrum Leipzig
state: Sachsen
city: Berlin
country: Germany
facility: Synexus - Prüfzentrum Berlin
city: Ulm Baden-Wuerttemberg
country: Germany
facility: Neuropoint GmbH
city: Pavia
country: Italy
facility: IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino
state: Lombardia
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: MI
city: Napoli
country: Italy
facility: AOU Luigi Vanvitelli
state: Naples
city: Rome
country: Italy
facility: IRCCS San Raffaele
state: Rome/lazio
city: Florence
country: Italy
facility: SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
city: Milan
country: Italy
facility: IRCCS Fondazione Besta
city: Modena
country: Italy
facility: University Modena e Reggio Emilia
city: Cuautitlan Izcalli
country: Mexico
facility: Phylasis Clinicas Research S. de R.L. de C.V.
state: Estado DE Mexico
city: Tlalnepantla de Baz
country: Mexico
facility: Clinical Research Institute S.C.
state: Estado DE Mexico
city: Merida
country: Mexico
facility: Medical Care and Research S.A. de C.V.
state: Yucatan
city: Aguascalientes
country: Mexico
facility: Centro de Investigación Médica de Aguascalientes (CIMA)
city: Ciudad de México
country: Mexico
facility: Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv
city: Mexico City
country: Mexico
facility: Clinstile, SA de CV
city: Wroclaw
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Neuromed
state: Kujawsko-pomorskie
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia Nowosolskie Centrum Medyczne
state: Lubuskie
city: Krakow
country: Poland
facility: Centermed Kraków Sp. Z o.o.
state: Malopolska
city: Warszawa
country: Poland
facility: Concept Medica
state: Mazowieckie
city: Warszawa
country: Poland
facility: Dr Sekowska Leczenie Bolu
state: Mazowieckie
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Damiana Walbrzyska
state: Mazowieckie
city: Oświęcim
country: Poland
facility: Instytut Zdrowia
state: Małopolska
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
city: Katowice
country: Poland
facility: Vita Longa Sp. Z o.o.
city: Szczecin
country: Poland
facility: MICS Centrum Medyczne Szczecin
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by Pratia
city: Wroclaw
country: Poland
facility: Premium Clinic Wrocław
city: Wroclaw
country: Poland
facility: Centrum Medyczne OPOROW
city: Łódź
country: Poland
facility: Centrum Leczenia Bolu dr n med Lukasz Kmieciak
state: Łódzkie
city: Elda
country: Spain
facility: Hospital Universitario de Elda
state: Alicante
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona Plato Headquarters
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Salamanca
country: Spain
facility: Hospital Universitario Ruber Juan Bravo
city: Santander
country: Spain
facility: University Hospital Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Virgen del Rocio University Hospital
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Solna
country: Sweden
facility: CTC Solna
state: Stockholms LÄN [se-01]
city: Uppsala
country: Sweden
facility: CTC MTC
state: Uppsala LÄN [se-03]
city: Goteborg
country: Sweden
facility: Carlanderska Hospital
city: Lund
country: Sweden
facility: Skåneuro Privatmottagning
city: Stockholm
country: Sweden
facility: Hälsoklustret
city: Stockholm
country: Sweden
facility: Akardo Med Site
city: Uppsala
country: Sweden
facility: University Hospital Uppsala (VO Neuro)
city: Edgebaston
country: United Kingdom
facility: Re: Cognition Health Ltd.
state: Birmingham
city: Hull
country: United Kingdom
facility: Hull University Hospitals NHS Trust
state: EAST Riding
city: Ilford
country: United Kingdom
facility: 4 Medical Clinical Solutions London
state: Essex
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospitals NHS Foundation Trust
state: Norfolk
city: Corby
country: United Kingdom
facility: Lakeside Healthcare Group Research
state: Northamptonshire
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
state: Scotland
city: Bristol
country: United Kingdom
facility: Cognition Health - Bristol
city: London
country: United Kingdom
facility: Kings College London
city: Swinton
country: United Kingdom
facility: 4 Medical Clinical Solutions
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: