Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications

Migraine Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518123
• Other study ID #: BHV3000-407
• Secondary ID: C4951012BHV3000-
• Status: Recruiting
• Phase: Phase 4
• Start date: November 7, 2022
• Est. completion date: February 11, 2025

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: Pfizer Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: February 11, 2025
• Est. primary completion date: February 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 28- day 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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Rimegepant
Rimegepant 75 mg Oral Disintegrating Tablet (ODT) taken every other day during Double-blind Treatment (DBT) phase
• Placebo
Matching placebo with every other day dosing during DBT phase

Locations

Country	Name	City	State
Australia	Genesis Research Services	Broadmeadow	New South Wales
Australia	Genesis Research Services	Newcastle	New South Wales
Australia	USC Clinical Trials Sunshine Coast	Sippy Downs	Queensland
Australia	PainMedSA & CerCare Pty Ltd	Wayville	South Australia
Austria	Medical University Innsbruck	Innsbruck	Tirol
Austria	Klinikum Klagenfurt am Wörthersee	Klagenfurt am Wörthersee
Austria	Medical University of Vienna	Vienna
Austria	Medical University of Vienna	Vienna
Belgium	GZA Ziekenhuizen	Antwerpen
Belgium	AZ Sint-Jan	Brugge
Belgium	AZ Sint-Jan Brugge-Oostende AV	Brugge
Belgium	UZ Brussel	Brussel
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	UZ Brussel	Jette	Brussels
Belgium	Clinique de la Citadelle	Liège
Belgium	Cabinet Privé Dr. Simona Sava	Saint Nicolas Province De Liège
Canada	NeuPath Centre for Pain and Spine	Brampton	Ontario
Canada	Centre de Recherche Saint-Louis/Clinique Neuro-Levis	Levis	Quebec
Canada	Clinique Neuro-Lévis	Levis	Quebec
Canada	Alpha Recherche Clinique	Quebec
Canada	ALPHA Recherche Clinique	Quebec
Canada	Diex Recherche Sherbrooke Inc.	Sherbrooke	Quebec
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Bispebjerg Hospital	Copenhagen NV	Capital Region
Denmark	Danish Headache Center	Glostrup	Region Hovedstaden
Denmark	Hospitalsenhed Midt	Viborg
Finland	Terveystalo Oy	Helsinki
Finland	Terveystalo Ruoholahti	Helsinki
Finland	Terveystalo Ruoholahti	Helsinki	Uusimaa
Finland	Terveystalo Tampere	Tampere
Finland	Terveystalo Pulssi	Turku
Germany	Zentrum für klinische Forschung	Bad Homburg	Hessen
Germany	Zentrum für klinische Forschung	Bad Homburg Hessen
Germany	Neurozentrum Tempelhof Berlin	Berlin
Germany	Synexus - Prüfzentrum Berlin	Berlin
Germany	Studiumzentrum Dr. A. Schwittay	Böhlen Sachsen
Germany	Kopfschmerzzentrum Frankfurt	Frankfurt
Germany	Kopfschmerzzentrum Frankfurt	Frankfurt	Hessen
Germany	Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre	Frankfurt am Main	Hessen
Germany	Schmerz- und Palliativzentrum Göppingen	Göppingen	Baden-wuerttemberg
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	Universitätsmedizin Greifswald	Greifswald	Mecklenburg-vorpommern
Germany	Synexus - Prüfzentrum Leipzig	Leipzig	Sachsen
Germany	Neuropoint GmbH	Ulm Baden-Wuerttemberg
Germany	Studienzentrum Nordwest	Westerstede
Germany	Studienzentrum Nordwest	Westerstede	Niedersachsen
Germany	Intermed GmbH	Wiesbaden	Hessen
Germany	Intermed GmbH	Wiesbaden Hessen
Italy	SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi	Florence
Italy	IRCCS Fondazione Besta	Milan
Italy	IRCCS Ospedale San Raffaele	Milano	MI
Italy	Ospedale San Raffaele	Milano	MI
Italy	AOU Policlinico di Modena	Modena, Emilia-Romagna	Modena
Italy	AOU Luigi Vanvitelli	Napoli	Naples
Italy	AOU Luigi Vanvitelli	Napoli	Naples
Italy	Fondazione Mondino - Istituto Neurologico Nazionale IRCCS	Pavia
Italy	IRCCS Fondazione Istituto Neurologico C. Mondino	Pavia
Italy	Clinical Trial Center IRCCS Mondino	Pavia (PV)	Pavia
Italy	Fondazione Policlinico Campus BioMedico	Rome	RM
Italy	IRCCS San Raffaele	Rome	Rome/lazio
Italy	IRCCS San Raffaele Roma	Rome
Mexico	Centro de Investigación Médica de Aguascalientes (CIMA)	Aguascalientes
Mexico	Unidad de Investigación En Salud de Chihuahua Sc	Alcadia Tlalpan	Ciudad DE Mexico
Mexico	Phylasis Clinicas Research S. de R.L. de C.V.	Cuautitlan Izcalli	Estado DE Mexico
Mexico	Medical Care and Research S.A. de C.V.	Merida	Yucatan
Mexico	Medical Care and Research S.A. de C.V.	Merida	Yucatan
Mexico	Clinstile, SA de CV	Mexico City
Mexico	Unidad de Investigación En Salud de Chihuahua Sc	Mexico City
Mexico	Clinical Research Institute S.C.	Tlalnepantla de Baz	Estado DE Mexico
Mexico	Clinical Research Institute S.C.	Tlalnepantla de Baz	Estado DE Mexico
Poland	Centrum Medyczne Neuromed	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne Pratia Katowice	Katowice
Poland	Vita Longa Sp. Z o.o.	Katowice
Poland	Centermed Kraków Sp. Z o.o.	Krakow	Malopolska
Poland	Centermed Kraków Sp. Z o.o.	Kraków
Poland	Centrum Leczenia Bolu dr n med Lukasz Kmieciak	Lódz	Lódzkie
Poland	Twoja Przychodnia Nowosolskie Centrum Medyczne	Nowa Sol	Lubuskie
Poland	Instytut Zdrowia	Oswiecim	Malopolska
Poland	MICS Centrum Medyczne Szczecin	Szczecin
Poland	Concept Medica	Warszawa	Mazowieckie
Poland	Dr Sekowska Leczenie Bolu	Warszawa	Mazowieckie
Poland	Dr Sekowska Leczenie Bolu	Warszawa
Poland	MICS Centrum Medyczne Damiana Walbrzyska	Warszawa	Mazowieckie
Poland	Praktyka Lekarska	Warszawa
Poland	Centrum Medyczne OPOROW	Wroclaw
Poland	Premium Clinic Wroclaw	Wroclaw
Spain	Hospital Clinic de Barcelona Plato Headquarters	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Universitario de Elda	Elda	Alicante
Spain	Hospital de la Princesa	Madrid	Madrid, Comunidad DE
Spain	Hospital HM Sanchinarro	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario HM Sanchinarro	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital HM Sanchinarro	Sanchinarro	Madrid, Comunidad DE
Spain	University Hospital Marqués de Valdecilla	Santander
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Virgen del Rocio University Hospital	Sevilla
Spain	Virgen del Rocio University Hospital	Sevilla
Spain	Consorcio Hospital General Universitario	Valencia
Spain	Consorcio Hospital General Universitario	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital General de Valencia	Valencia	València
Spain	Hospital Clinico Universitario de Valladolid	Valladolid
Spain	Hospital Universitario de Valladolid	Valladolid
Sweden	Carlanderska Hospital	Goteborg
Sweden	Carlanderska Hospital	Gothenburg
Sweden	Skåneuro Privatmottagning	Lund
Sweden	CTC Solna	Solna	Stockholms LÄN [se-01]
Sweden	Akardo Med Site	Stockholm
Sweden	Akardo Med Site	Stockholm
Sweden	Hälsoklustret	Stockholm
Sweden	CTC MTC	Uppsala	Uppsala LÄN [se-03]
Sweden	CTC Uppsala	Uppsala	Uppsala LÄN [se-03]
Sweden	CTC Uppsala	Uppsala
Sweden	University Hospital Uppsala (VO Neuro)	Uppsala
United Kingdom	Re:Cognition Health - Birmingham	Birmingham
United Kingdom	Cognition Health - Bristol	Bristol
United Kingdom	Cognition Health - Bristol	Bristol
United Kingdom	Lakeside Healthcare Group Research	Corby	Northamptonshire
United Kingdom	Cognition Health - Birmingham	Edgbaston	Birmingham
United Kingdom	Re: Cognition Health Ltd.	Edgebaston	Birmingham
United Kingdom	James Paget University Hospital	Great Yarmouth	Norfolk
United Kingdom	James Paget University Hospital	Great Yarmouth	Other
United Kingdom	James Paget University Hospitals NHS Foundation Trust	Great Yarmouth	Norfolk
United Kingdom	Hull University Hospitals NHS Trust	Hull	EAST Riding
United Kingdom	Hull University Hospitals NHS Trust	Hull	EAST Riding
United Kingdom	Hull University Hospitals NHS Trust	Hull
United Kingdom	The Walton Centre NHS Foundation Trust	Liverpool
United Kingdom	Kings College London	London
United Kingdom	The Oxford University Hospitals NHS Foundation Trust	Oxford	Oxfordshire
United Kingdom	South Tyneside and Sunderland NHS Foundation Trust	Sunderland, Tyne & Wear
United Kingdom	4 Medical Clinical Solutions	Swinton, Manchester
United States	Albuquerque Clinical Trials. Inc.	Albuquerque	New Mexico
United States	Synexus Clinical Research US, Inc. - Anderson	Anderson	South Carolina
United States	Michigan Headache & Neurological Institute	Ann Arbor	Michigan
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	DM Clinical Research - Brooklyn	Brooklyn	New York
United States	DM Clinical Research - NY, NY	Brooklyn	New York
United States	Complete Health Research	Edgewater	Florida
United States	Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit	Edgewater	Florida
United States	Headache Wellness Center, PC	Greensboro	North Carolina
United States	Alliance for Multispecialty Reseach, LLC	Knoxville	Tennessee
United States	Wr-Msra,Llc	Lake City	Florida
United States	Red Star Research, LLC	Lake Jackson	Texas
United States	Wr-Crcn, Llc	Las Vegas	Nevada
United States	Community Clinical Research Network, Inc.	Marlborough	Massachusetts
United States	AppleMed Research Group, LLC	Miami	Florida
United States	DiGiovanna Institute for Medical Education And Research	North Massapequa	New York
United States	Sensible Healthcare LLC	Ocoee	Florida
United States	Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit	Ormond Beach	Florida
United States	Rochester Medical Group	Rochester Hills	Michigan
United States	StudyMetrix Research	Saint Peters	Missouri
United States	California Neuroscience Research, LLC	Sherman Oaks	California
United States	DM Clinical Research - Detroit, MI	Southfield	Michigan
United States	Clinvest Research, LLC	Springfield	Missouri
United States	Clinvest Research, LLC	Springfield	Missouri
United States	Ki Health Partners LLC, dba New England Institute for Clinical Research	Stamford	Connecticut
United States	DM Clinical Research	Tomball	Texas
United States	St Charles Clinical Research	Weldon Spring	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  Finland,  Germany,  Italy,  Mexico,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the efficacy of rimegepant (75 mg) to placebo	Subjects are dosed every other day, for the preventative treatment of migraine as measured by mean change in number of migraine days per month (28 days) over 12 week DBT Phase. A migraine day is any calendar day in which the subject experiences a qualified migraine headache. This includes any calendar day in which the subject takes an acute migraine-specific medication.	Week 1 to 12 of DBT Phase

External Links

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