Clinical trial NCT05217927: Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
Official title: A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine
Episodic Migraine
Adult Migraine
Calcitonin Gene-related Peptide
Migraine Prevention
Migraine Prophylaxis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-02-01
Enrollment: 698
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: The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.


Eligibility criteria: Inclusion Criteria:

1) Target Population: Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:

1. Age of onset of migraines prior to 50 years of age
2. Migraine attacks, on average, lasting 4-72 hours if untreated
3. Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol

Exclusion Criteria:

1. Sex and Reproductive Status:

   1. WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug
   2. Women who are pregnant or breastfeeding
   3. Women with a positive pregnancy test at screening or prior to study drug administration
2. Prohibited Medications:

   1. Use of prophylactic migraine medication within 30 days prior to the Screening Visit.
   2. History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
   3. Use of medication accepted for treatment of acute migraine for a nonmigraine indication on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
   4. Subjects who previously discontinued biologic migraine medication must have done so at least 6 months (24 weeks) prior to the Screening Visit.
   5. Subjects taking a prohibited medication as defined per protocol

Primary outcomes:
measure: Mean change from the Observation Phase in the number of migraine days per month over the entire Double-blind Treatment Phase (Weeks 1-12)
timeFrame: 3 months (12 weeks)
Secondary outcomes:
measure: Proportion of subjects with > 50% reduction from the Observation Phase (Weeks 1 to 12).
timeFrame: 3 months (12 weeks)
measure: Mean change from the Observation Phase.
timeFrame: Weeks 9 to 12
measure: Mean change from the Observation Phase
timeFrame: Weeks 1 to 4
measure: Mean number of acute migraine-specific medication days per month.
timeFrame: Weeks 1 to 12
measure: Mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) restrictive role function.
timeFrame: At Week 12
measure: Number and percentage of subjects with AEs by intensity.
timeFrame: 24 Weeks
measure: Number and percentage of subjects treated with rimegepant with AST or ALT elevations.
timeFrame: 24 Weeks
measure: Number and percentage of subjects treated with rimegepant with hepatic-related AEs
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Arizona
city: Colton
country: United States
facility: Axiom Research, Llc
state: California
city: Los Angeles
country: United States
facility: Clinical Research Institute
state: California
city: Newport Beach
country: United States
facility: Wr-Pri, Llc
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, inc.
state: California
city: Boca Raton
country: United States
facility: Neurology Offices of South Florida, PLLC
state: Florida
city: Miami
country: United States
facility: AppleMed Research Group, LLC
state: Florida
city: Gurnee
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Overland Park
country: United States
facility: Collective Medical Research
state: Kansas
city: Springfield
country: United States
facility: Clinvest Research, LLC
state: Missouri
city: Las Vegas
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Nevada
city: Amherst
country: United States
facility: Dent Neurosciences Research Center, Inc.
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates, LLC
state: New York
city: Columbus
country: United States
facility: Wellnow Urgent Care and Research
state: Ohio
city: Huber Heights
country: United States
facility: WellNow Urgent Care and Research
state: Ohio
city: Troy
country: United States
facility: Wellnow Urgent Care and Research
state: Ohio
city: Medford
country: United States
facility: Velocity Clinical Research, Medford
state: Oregon
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research - Providence
state: Rhode Island
city: Columbia
country: United States
facility: Velocity Clinical Research - Columbia
state: South Carolina
city: Gaffney
country: United States
facility: Velocity Clinical Research, Gaffney
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research LLC
state: South Carolina
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Magnolia
country: United States
facility: APD Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research , LLC(Administrative Location)
state: Utah
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck
state: Tirol
city: Salzburg
country: Austria
facility: Christian-Doppler-Klinik
city: Calgary
country: Canada
facility: Calgary Headache & Assessment Management Program (CHAMP)
state: Alberta
city: Kelowna
country: Canada
facility: OCT Research ULC
state: British Columbia
city: Vancouver
country: Canada
facility: James K. Lai MD Inc.
state: British Columbia
city: Halifax
country: Canada
facility: Centricity Research
state: Nova Scotia
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: Burlington
country: Canada
facility: Manna Research Inc. (Burlington North)
state: Ontario
city: London
country: Canada
facility: Milestone Research Inc.
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Stouffville
country: Canada
facility: Mirtorabi Medicine Professional Corporation
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Toronto
country: Canada
facility: Manna Research (Toronto)
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: Quebec
city: Clermont-Ferrand cedex
country: France
facility: Hopital Gabriel Montpied
city: Marseille
country: France
facility: Hopital de La Timone
city: Karlsruhe
country: Germany
facility: Klinische Forschung Karlsruhe GmbH
state: Baden-württemberg
city: Kassel
country: Germany
facility: Vitos Orthopaedische Klinik Kassel
state: Hessen
city: Westerstede
country: Germany
facility: Arztepartnerschaft Dr. med. J. Springub/ W. Schwarz -Studienzentrum Nord-West
state: Lower Saxony
city: Hanover
country: Germany
facility: Siteworks - Zentrum fur klinische Studien Hannover
state: Lower-saxony
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
state: Mecklenburg-vorpommern
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
state: Saxony
city: Jena
country: Germany
facility: Universitatsklinikum Jena
state: Thuringia
city: Böhlen
country: Germany
facility: Studienzentrum Dr. A Schwittay
city: Frankfurt
country: Germany
facility: Kopfschmerzzentrum Frankfurt
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Kiel
country: Germany
facility: Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
city: Koeln
country: Germany
facility: Datamed GmbH
city: Roma
country: Italy
facility: Ospedale Sant Andrea - Facolta Medicina Psicologia - Universita degli Studi di Roma Sapienza
state: Lazio
city: Pavia
country: Italy
facility: Fondazione Mondino - Istituto Neurologico Nazionale IRCCS
state: Padua
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria di Careggi - Cliniche Mediche
state: Tuscany
city: Bologna
country: Italy
facility: IRCCS Istituto delle Scienze Neurologiche Bologna, Unità Operativa di Neurologia - Ospedale Bellaria
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia, U.O. Neurologia
city: Latina
country: Italy
facility: Neurorehabilitation Unit-ICOT Istituto Marco Pasquali
city: Milan
country: Italy
facility: Istituto Neurologico "Carlo Besta" Fondazione IRCCS
city: Rome
country: Italy
facility: IRCCS San Raffaele Roma
city: Wroclaw
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej
state: Lubelskie
city: Krakow
country: Poland
facility: Krakowska Akademia Neurologii Sp. Z o.o.
state: Malopolskie
city: Warszawa
country: Poland
facility: Next Stage Sp. Z o.o.
state: Mazowieckie
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
state: Mazowieckie
city: Krakow
country: Poland
facility: Pratia MCM Krakow
state: Małopolskie
city: Czestochowa
country: Poland
facility: Centrum Medyczne Pratia Czestochowa
state: Slaskie
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
state: Slaskie
city: Katowice
country: Poland
facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
state: Slaskie
city: Katowice
country: Poland
facility: Neurologia Slaska Centrum Medyczne
state: Slaskie
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne
state: Wielkopolskie
city: Lublin
country: Poland
facility: NZOZ Neuromed M. i M. Nastaj Sp. P.
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by Pratia
city: Santander
country: Spain
facility: Neurology Service: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid • HCUV
state: Castilla Y LEON
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: Pontevedra
city: Madrid
country: Spain
facility: Instituto de Investigaciones del Sueno
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Virgen del Rocio Hospital
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Malmö
country: Sweden
facility: Pharmasite
state: Skåne
city: Stockholm
country: Sweden
facility: CTC Clinical Trial Consultants AB
state: Stockholms LÄN [se-01]
city: Boraas
country: Sweden
facility: Ladulaas Clinical Trials
city: Lund
country: Sweden
facility: ProbarE i Lund
city: Stockholm
country: Sweden
facility: ProbarE i Stockholm AB
city: Stockholm
country: Sweden
facility: Studieenheten Akademiskt Specialistcentrum SLSO
city: Chesterfield
country: United Kingdom
facility: Royal Primary Care Ashgate, Chesterfield Royal Hospital, NHS Foundation Trust
state: Derbyshire
city: Rochdale
country: United Kingdom
facility: Panthera Biopartners
state: Great Manchester
city: Winchester
country: United Kingdom
facility: Re:Cognition Health - Winchester
state: Hampshire
city: Preston
country: United Kingdom
facility: Panthera Bio Partners
state: Lancashire
city: London
country: United Kingdom
facility: Re:Cognition Health - London
state: Marylebone
city: London
country: United Kingdom
facility: Re:Cognition Health-Private Practice
state: Marylebone
city: Corby
country: United Kingdom
facility: Lakeside Healthcare Research
state: Northamptonshire
city: Glasgow
country: United Kingdom
facility: CPS Research
state: Scotland
city: Bristol
country: United Kingdom
facility: Re-Cognition Health - Bristol
state: South WEST
city: Sheffield
country: United Kingdom
facility: Panthera Biopartners - Sheffield
state: South Yorkshire
city: Guildford
country: United Kingdom
facility: Re-Cognition Health
state: Surrey
city: Birmingham
country: United Kingdom
facility: Re-Cognition Health
state: WEST Midlands
city: Glasgow
country: United Kingdom
facility: Panthera Biopartners Glasgow
city: London
country: United Kingdom
facility: Panthera Biopartners - Enfield
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: