Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

Migraine Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05217927
• Other study ID #: BHV3000-404
• Secondary ID: C49510102021-005
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 4, 2022
• Est. completion date: December 8, 2024

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 453
• Est. completion date: December 8, 2024
• Est. primary completion date: October 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Rimegepant 75mg daily dosing
Daily
• Rimegepant 75mg every other day dosing
Every other day
• Placebo comparator dosing
Placebo comparator

Locations

Country	Name	City	State
Austria	Medizinische Universitat Innsbruck	Innsbruck	Tirol
Austria	Christian-Doppler-Klinik	Salzburg
Austria	Paracelsus Medizinischen Privatuniversitaet - Christian-Doppler-Klinik (CDK)	Salzburg
Canada	Aggarwal and Associates Limited	Brampton	Ontario
Canada	Manna Research Inc. (Burlington North)	Burlington	Ontario
Canada	Calgary Headache & Assessment Management Program (CHAMP)	Calgary	Alberta
Canada	Centricity Research	Halifax	Nova Scotia
Canada	True North Clinical Research Inc.	Halifax	Nova Scotia
Canada	OCT Research ULC	Kelowna	British Columbia
Canada	Milestone Research Inc.	London	Ontario
Canada	Bluewater Clinical Research Group Inc.	Sarnia	Ontario
Canada	Diex Recherche Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Mirtorabi Medicine Professional Corporation	Stouffville	Ontario
Canada	Manna Research (Toronto)	Toronto	Ontario
Canada	Toronto Memory Program	Toronto	Ontario
Canada	James K. Lai MD Inc.	Vancouver	British Columbia
France	Hopital Gabriel Montpied	Clermont-Ferrand cedex
France	Hopital Roger Salengro CHU Lille	Lille Cedex
France	Hopital de La Timone	Marseille
France	Centre Hospitalier Annecy Genevois	Pringy Cedex
Germany	Klinische Forschung Berlin-Mitte	Berlin
Germany	Neurologisches Facharztzentrum Berlin (NFZB) - Sankt Gertrauden-Krankenhaus Location	Berlin
Germany	Studienzentrum Dr. A Schwittay	Böhlen
Germany	Studienzentrum Dr. A Schwittay	Böhlen
Germany	Klinische Forschung Dresden GmbH	Dresden
Germany	Universitaetsklinikum Essen - Klinik und Poliklinik fuer Neurologie - Schwindel-Zentrum Essen	Essen
Germany	Kopfschmerzzentrum Frankfurt	Frankfurt
Germany	Klinische Forschung Hamburg GmbH	Hamburg
Germany	Zentrum für klinische Studien Hannover	Hannover
Germany	Siteworks - Zentrum fur klinische Studien Hannover	Hanover	Lower-saxony
Germany	Universitatsklinikum Jena	Jena	Thuringia
Germany	Klinische Forschung Karlsruhe GmbH	Karlsruhe	Baden-württemberg
Germany	Klinische Forschung Karlsruhe GmbH	Karlsruhe
Germany	Vitos Orthopaedische Klinik Kassel	Kassel	Hessen
Germany	Neurologisch-verhaltensmedizinische Schmerzklinik Kiel	Kiel
Germany	Datamed GmbH	Koeln
Germany	NeuroMed Campus - Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus	Koln
Germany	Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik	Muenchen	Bavaria
Germany	Ludwig-Maximilians-Universitaet Muenchen Klinikum der Universitaet Muenchen - Campus Grosshadern	Munich
Germany	Klinische Forschung Schwerin GmbH	Schwerin
Germany	Klinische Forschung Schwerin GmbH	Schwerin	Mecklenburg-vorpommern
Germany	Arztepartnerschaft Dr. med. J. Springub/ W. Schwarz -Studienzentrum Nord-West	Westerstede	Lower Saxony
Germany	Fachuebergreifende Gemeinschaftspraxis Dr.Med. Joachim Springub & Wolfgang Schwarz	Westerstede
Italy	Azienda Ospedaliera San Giuseppe Moscati-Unita di Neurologia	Avellino
Italy	IRCCS Istituto delle Scienze Neurologiche Bologna, Unità Operativa di Neurologia - Ospedale Bellaria	Bologna
Italy	ASST Spedali Civili di Brescia, U.O. Neurologia	Brescia
Italy	AOU Careggi - Centro Cefalee	Firenze	Florence
Italy	Azienda Ospedaliero Universitaria di Careggi - Cliniche Mediche	Florence	Tuscany
Italy	Neurorehabilitation Unit-ICOT Istituto Marco Pasquali	Latina
Italy	Istituto Neurologico "Carlo Besta" Fondazione IRCCS	Milan
Italy	Azienda Ospedaliera Universitaria Luigi Vanvitelli	Napoli	Campania
Italy	Fondazione Mondino - Istituto Neurologico Nazionale IRCCS	Pavia	Padua
Italy	Ospedale Sant Andrea - Facolta Medicina Psicologia - Universita degli Studi di Roma Sapienza	Roma	Lazio
Italy	Azienda Ospedaliera Sant'Andrea, UOC Neurologia	Rome
Italy	IRCCS San Raffaele Roma	Rome
Italy	Centro per la Diagnosi e Terapia delle Cefalee Azienda Ospedaliero-Universitaria di Trieste	Trieste	Friuli-venezia Giulia
Italy	Ospedale di Cattinara, Centro per la Diagnosi e Terapia delle Cefalee	Trieste
Poland	Centrum Medyczne Pratia Bydgoszcz	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne Pratia Czestochowa	Czestochowa	Slaskie
Poland	Centrum Medyczne Pratia Katowice	Katowice	Slaskie
Poland	NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS	Katowice	Slaskie
Poland	Krakowska Akademia Neurologii Sp. Z o.o.	Krakow	Malopolskie
Poland	Krakowska Akademia Neurologil Sp. Z o.o.	Krakow	Malopolskie
Poland	Pratia MCM Krakow	Krakow	Malopolskie
Poland	Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej	Lublin	Lubelskie
Poland	NZOZ Neuromed M. i M. Nastaj Sp. P.	Lublin
Poland	Solumed Centrum Medyczne	Poznan	Wielkopolskie
Poland	MTZ Clinical Research Powered by Pratia	Warszawa
Poland	Next Stage Sp. Z o.o.	Warszawa	Mazowieckie
Poland	Next Stage Sp. Z o.o.	Warszawa	Mazowieckie
Poland	Wojskowy Instytut Medyczny	Warszawa	Mazowieckie
Poland	MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak	Wroclaw	Dolnoslaskie
Spain	Hospital Universitario La Paz	Madrid
Spain	Instituto de Investigaciones del Sueno	Madrid
Spain	Neurology Service: Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Virgen del Rocio Hospital	Sevilla
Spain	Hospital Universitario y Politecnico La Fe	Valencia
Spain	Hospital Clinico Universitario de Valladolid • HCUV	Valladolid	Castilla Y LEON
Spain	Hospital Alvaro Cunqueiro	Vigo	Pontevedra
Sweden	Ladulaas Clinical Trials	Boraas
Sweden	Ladulaas Clinical Trials	Boraas
Sweden	Ladulaas Clinical Trials	Boras	SE
Sweden	ProbarE i Lund	Lund
Sweden	Pharmasite	Malmö
Sweden	Pharmasite	Malmö	Skåne
Sweden	CTC Clinical Trial Consultants AB	Stockholm	Stockholms LÄN [se-01]
Sweden	ProbarE i Stockholm AB	Stockholm
Sweden	Studieenheten Akademiskt Specialistcentrum SLSO	Stockholm
United Kingdom	Re-Cognition Health	Birmingham	WEST Midlands
United Kingdom	Re-Cognition Health - Bristol	Bristol	South WEST
United Kingdom	Royal Primary Care Ashgate, Chesterfield Royal Hospital, NHS Foundation Trust	Chesterfield	Derbyshire
United Kingdom	Lakeside Healthcare Research	Corby	Northamptonshire
United Kingdom	CPS Research	Glasgow	Scotland
United Kingdom	Intelligent Clinical	Glasgow	Lanarkshire
United Kingdom	Panthera Biopartners Glasgow	Glasgow
United Kingdom	Re-Cognition Health	Guildford	Surrey
United Kingdom	Kings College Hospital	London
United Kingdom	Panthera Biopartners - Enfield	London
United Kingdom	Re:Cognition Health - London	London	Marylebone
United Kingdom	Re:Cognition Health Limited	London
United Kingdom	Re:Cognition Health-Private Practice	London	Marylebone
United Kingdom	Panthera Bio Partners	Preston	Lancashire
United Kingdom	Panthera Biopartners	Rochdale	Great Manchester
United Kingdom	Panthera Biopartners - Sheffield	Sheffield	South Yorkshire
United Kingdom	Re:Cognition Health - Winchester	Winchester	Hampshire
United States	Dent Neurosciences Research Center, Inc.	Amherst	New York
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Neurology Offices of South Florida, PLLC	Boca Raton	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	Axiom Research, Llc	Colton	California
United States	Velocity Clinical Research - Columbia	Columbia	South Carolina
United States	Wellnow Urgent Care and Research	Columbus	Ohio
United States	Wellnow Urgent Care and Research	Columbus	Ohio
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	WellNow Urgent Care and Research	Dayton	Ohio
United States	Velocity Clinical Research - Providence	East Greenwich	Rhode Island
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Velocity Clinical Research, Gaffney	Gaffney	South Carolina
United States	Tribe Clinical Research LLC	Greenville	South Carolina
United States	Clinical Investigation Specialists, Inc.	Gurnee	Illinois
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	WellNow Urgent Care and Research	Huber Heights	Ohio
United States	Alliance for Multispecialty Research, LLC	Las Vegas	Nevada
United States	Clinical Research Institute	Los Angeles	California
United States	APD Clinical Research	Magnolia	Texas
United States	Velocity Clinical Research, Medford	Medford	Oregon
United States	AppleMed Research Group, LLC	Miami	Florida
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Wr-Pri, Llc	Newport Beach	California
United States	Collective Medical Research	Overland Park	Kansas
United States	Preferred Primary Care Physicians, Inc.	Pittsburgh	Pennsylvania
United States	Collective Medical Research	Prairie Village	Kansas
United States	Wasatch Clinical Research , LLC(Administrative Location)	Salt Lake City	Utah
United States	Seattle Clinical Research Center	Seattle	Washington
United States	California Neuroscience Research Medical Group, inc.	Sherman Oaks	California
United States	Clinvest Research, LLC	Springfield	Missouri
United States	Alliance for Multispecialty Research, LLC	Tempe	Arizona
United States	Wellnow Urgent Care and Research	Troy	Ohio
United States	Upstate Clinical Research Associates, LLC	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Italy,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from the Observation Phase in the number of migraine days per month over the entire Double-blind Treatment Phase (Weeks 1-12)	Change from baseline in mean number of migraine days per month	3 months (12 weeks)
Secondary	Proportion of subjects with > 50% reduction from the Observation Phase (Weeks 1 to 12).	Number of moderate to severe migraine days per month over the entire Double-blind Treatment Phase	3 months (12 weeks)
Secondary	Mean change from the Observation Phase.	Number of migraine days per month in the last 4 weeks of the Double-blind Treatment Phase.	Weeks 9 to 12
Secondary	Mean change from the Observation Phase	number of migraine days per month in the first 4 weeks of the Double-blind Treatment Phase.	Weeks 1 to 4
Secondary	Mean number of acute migraine-specific medication days per month.	Over the entire Double-blind Treatment Phase. Acute migraine-specific medications are triptans and ergotamine.	Weeks 1 to 12
Secondary	Mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) restrictive role function.	Domain score of the Double-blind Treatment Phase.	At Week 12
Secondary	Number and percentage of subjects with AEs by intensity.	Serious adverse events (SAEs), AEs leading to study drug discontinuation, and grade 3 to 4 laboratory test abnormalities during the Double-blind Treatment and Open-label Extension Phases.	24 Weeks
Secondary	Number and percentage of subjects treated with rimegepant with AST or ALT elevations.	>3x ULN concurrent (i.e., on the same laboratory collection date) with total bilirubin > 2x ULN during the Double-blind Treatment and Open-label Extension Phases.	24 Weeks
Secondary	Number and percentage of subjects treated with rimegepant with hepatic-related AEs	By intensity and hepatic-related AEs leading to study drug discontinuation during the Double-blind Treatment and Open-label Extension Phases.	24 Weeks

External Links

•   To obtain contact information for a study center near you, click here.