Clinical trial NCT05509400: Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine
Acute Migraine
Headache
Acute treatment of Migraine in adults unsuitable for triptans
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 633
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

Detailed description: 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). Rimegepant will be further evaluated in this population with as needed use in a 12-week, open-label extension study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

-Target Disease Exclusion:

1. History of cluster headache, basilar migraine, or hemiplegic migraine
2. Current medication overuse headaches
3. Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit
4. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \[CRPS\])
5. 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 with placebo in the acute treatment of migraine, as measured by migraine headache pain relief at 2-hours post-dose during the Double-Blind Treatment (DBT) Phase.
timeFrame: 2 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical Research Institute
state: California
city: Stamford
country: United States
facility: Ki Health Partners LLC, dba New England Institute for Clinical Research
state: Connecticut
city: Lake City
country: United States
facility: Wr-Msra, 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: Sandy Springs
country: United States
facility: WR-Mount Vernon Clinical Research, LLC
state: Georgia
city: Overland Park
country: United States
facility: Collective Medical Research
state: Kansas
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
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: Southfield
country: United States
facility: DM Clinical Research - Detroit
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: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: DM Clinical Research - NY, NY
state: New York
city: New York
country: United States
facility: New York Neurology Associates
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: 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 Centre
state: Queensland
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Klagenfurt am Wörthersee
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
state: Carinthia
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tirol
city: Saint Nicolas
country: Belgium
facility: Cabinet Privé Dr. Simona Sava
state: Liège
city: Antwerpen
country: Belgium
facility: GZA Ziekenhuizen
city: Brussels
country: Belgium
facility: UZ Brussel
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Calgary
country: Canada
facility: University of Calgary South Health Campus
state: Alberta
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: Levis
country: Canada
facility: Clinique Neuro-Lévis
state: Quebec
city: Quebec
country: Canada
facility: ALPHA Recherche Clinique
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Esbjerg
country: Denmark
facility: University Hospital of Southern Denmark
city: Glostrup
country: Denmark
facility: Danish Headache Center
city: Viborg
country: Denmark
facility: Hospitalsenhed Midt
city: Helsinki
country: Finland
facility: Helsinki Headache Center
state: Uusimaa
city: Helsinki
country: Finland
facility: Terveystalo Ruoholahti
city: Tampere
country: Finland
facility: Terveystalo Tampere Rautatienkatu
city: Turku
country: Finland
facility: Terveystalo Pulssi
city: Marseille
country: France
facility: Timone Hospital
state: Provence
city: Bron
country: France
facility: Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand - Hopital Gabriel Montpied
city: Epagny Metz-Tessy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Lille
country: France
facility: CHU de Lille - Hôpital Salengro
city: Nice
country: France
facility: CHU Nice Hopital Cimiez
city: Paris
country: France
facility: Hopital Lariboisiere
city: Saint-Etienne Cedex 2
country: France
facility: CHU Saint-Etienne - Hopital Nord
city: Kiel
country: Germany
facility: Neurologische Praxis Prof. Dr. Hartmut Gobel
state: Schleswig-holstein
city: Jena
country: Germany
facility: University Hospital Jena
state: Thüringen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin, Neurologische Ambulanz, Kopfschmerzambulanz
city: Frankfurt
country: Germany
facility: Kopfschmerzzentrum Frankfurt
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: Fondazione Policlinico Campus BioMedico
state: RM
city: Milano
country: Italy
facility: Foundation IRCCS Neurological Institute Carlo Besta
city: Modena
country: Italy
facility: AOU Policlinico di Modena
city: Pavia
country: Italy
facility: Fondazione Mondino - Istituto Neurologico Nazionale IRCCS
city: Rome
country: Italy
facility: Headache and Pain Unit - IRCCS San Raffaele
city: Tlalnepantla de Baz
country: Mexico
facility: Clinical Research Institute S.C.
state: Estado DE Mexico
city: Aguascalientes
country: Mexico
facility: Centro de Investigación Médica de Aguascalientes (CIMA)
city: Mexico City
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: Warszawa
country: Poland
facility: Concept Medica
state: Mazowieckie
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Damiana Walbrzyska
state: Mazowieckie
city: Oświęcim
country: Poland
facility: Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k.
state: Małopolska
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: Praktyka Lekarska
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by Pratia
city: Łódź
country: Poland
facility: Centrum Leczenia Bolu dr n med Lukasz Kmieciak
state: Łódzkie
city: Santander
country: Spain
facility: University Hospital Marqués de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Virgen del Rocio University Hospital
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Solna
country: Sweden
facility: CTC Solna
state: Stockholms LÄN [se-01]
city: Uppsala
country: Sweden
facility: CTC Uppsala
state: Uppsala LÄN
city: Lund
country: Sweden
facility: Skåneuro Privatmottagning
city: Stockholm
country: Sweden
facility: Hälsoklustret
city: Stockholm
country: Sweden
facility: Akardo MedSite
city: Edgebaston
country: United Kingdom
facility: Re: Cognition Health Ltd.
state: Birmingham
city: Ilford
country: United Kingdom
facility: 4 Medical Clinical Solutions London
state: Essex
city: Corby
country: United Kingdom
facility: Lakeside Healthcare Group Research
state: Northamptonshire
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: