Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

Migraine Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509400
• Other study ID #: BHV3000-406
• Secondary ID: C49510042022-001
• Status: Recruiting
• Phase: Phase 4
• Start date: October 18, 2022
• Est. completion date: February 18, 2025

Study information

• Verified date: May 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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: February 18, 2025
• Est. primary completion date: November 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Rimegepant
DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT)
• Placebo
DB Phase: matching placebo
• Rimegepant
OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria
Australia	USC Clinical Trials Centre	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	Klinikum Klagenfurt am Wörthersee	Klagenfurt am Wörthersee	Carinthia
Austria	Medical University of Vienna	Vienna
Belgium	GZA Ziekenhuizen	Antwerpen
Belgium	UZ Brussel	Brussels
Belgium	UZ Gent	Gent
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	Cabinet Privé Dr. Simona Sava	Saint Nicolas	Liège
Belgium	Cabinet Privé Dr. Simona Sava	Saint Nicolas Province De Liège
Canada	NeuPath Centre for Pain and Spine	Brampton	Ontario
Canada	University of Calgary South Health Campus	Calgary	Alberta
Canada	Clinique Neuro-Lévis	Levis	Quebec
Canada	Alpha Recherche Clinique	Quebec
Canada	Alpha Recherche Clinique	Quebec
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Bispebjerg Hospital	Copenhagen NV	Capital Region
Denmark	Danish Headache Center	Glostrup
Denmark	Hospitalsenhed Midt	Viborg
Finland	Helsinki Headache Center	Helsinki	Uusimaa
Finland	Helsinki Headache Center	Helsinki	Uusimaa
Finland	Terveystalo Ruoholahti	Helsinki
Finland	Terveystalo Pulssi	Turku
France	CHU Lyon Hôpital Pierre Wertheimer	Bron
France	Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer	Bron
France	CHU Clermont Ferrand - Hopital Gabriel Montpied	Clermont-Ferrand
France	Centre Hospitalier Annecy Genevois	Epagny Metz-Tessy
France	Centre Hospitalier Annecy Genevois	Epagny Metz-Tessy	Haute-savoie
France	CHU de Lille - Hôpital Salengro	Lille
France	Timone Hospital	Marseille
France	Timone Hospital	Marseille	Provence
France	CHU Nice Hopital Cimiez	Nice
France	Hopital Lariboisiere	Paris
France	CHU Saint-Etienne, Hopital Nord	Saint Priest en Jarez	Loire
France	CHU Saint-Etienne - Hopital Nord	Saint-Etienne Cedex 2
Germany	Charité Universitätsmedizin Berlin, Neurologische Ambulanz, Kopfschmerzambulanz	Berlin
Germany	Kopfschmerzzentrum Frankfurt	Frankfurt
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	Universitätsmedizin Greifswald	Greifswald	Mecklenburg-vorpommern
Germany	University Hospital Jena	Jena
Germany	University Hospital Jena	Jena	Thüringen
Germany	Vitos Orthopaedische Klinik Kassel	Kassel	Hessen
Germany	Neurologische Praxis Prof. Dr. Hartmut Gobel	Kiel	Schleswig-holstein
Germany	Neurologische Praxis Prof. Dr. Hartmut Gobel	Kiel
Germany	Schmerzklinik Kiel	Kiel
Germany	Helios DKD Hospital Wiesbaden	Wiesbaden
Italy	Foundation IRCCS Neurological Institute Carlo Besta	Milano
Italy	IRCCS Ospedale San Raffaele	Milano	MI
Italy	AOU Luigi Vanvitelli	Napoli	Naples
Italy	Fondazione Mondino - Istituto Neurologico Nazionale IRCCS	Pavia
Italy	IRCCS San Raffaele Roma	Roma	Rome
Italy	Fondazione Policlinico Campus BioMedico	Rome	RM
Italy	Headache and Pain Unit - IRCCS San Raffaele	Rome
Mexico	Centro de Investigación Médica de Aguascalientes (CIMA)	Aguascalientes
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
Poland	Centrum Medyczne Neuromed	Bydgoszcz	Kujawsko-pomorskie
Poland	Vita Longa Sp. Z o.o.	Katowice
Poland	Centrum Leczenia Bolu dr n med Lukasz Kmieciak	Lódz	Lódzkie
Poland	Twoja Przychodnia Nowosolskie Centrum Medyczne	Nowa Sol	Lubuskie
Poland	Twoja Przychodnia Nowosolskie Centrum Medyczne	Nowa Sol	Lubuskie
Poland	Instytut Zdrowia	Oswiecim	Malopolska
Poland	Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k.	Oswiecim	Malopolska
Poland	MICS Centrum Medyczne Szczecin	Szczecin
Poland	Concept Medica	Warszawa	Mazowieckie
Poland	MICS Centrum Medyczne Damiana Walbrzyska	Warszawa	Mazowieckie
Poland	Praktyka Lekarska	Warszawa
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Universitario La Paz	Madrid
Spain	University Hospital Marqués de Valdecilla	Santander	Cantabria
Spain	University Hospital Marqués de Valdecilla	Santander	Cantabria
Spain	Virgen del Rocio University Hospital	Sevilla
Spain	Hospital Clínico Universitario de Valencia	Valencia
Sweden	Skåneuro Privatmottagning	Lund
Sweden	CTC Solna	Solna	Stockholms LÄN [se-01]
Sweden	CTC AB	Solna Stockholm
Sweden	Akardo MedSite	Stockholm
Sweden	Hälsoklustret	Stockholm
Sweden	CTC Uppsala	Uppsala
Sweden	CTC Uppsala	Uppsala	Uppsala LÄN
United Kingdom	Lakeside Healthcare Group Research	Corby	Northamptonshire
United Kingdom	Re: Cognition Health Ltd.	Edgebaston	Birmingham
United Kingdom	Kings College London	London
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford	Oxfordshire
United Kingdom	4 Medical Clinical Solutions	Swinton, Manchester
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 - 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	Wr-Msra, Llc	Lake City	Florida
United States	Red Star Research, LLC	Lake Jackson	Texas
United States	Clinical Research Institute	Los Angeles	California
United States	Community Clinical Research Network Inc	Marlborough	Massachusetts
United States	AppleMed Research Group, LLC	Miami	Florida
United States	DelRicht Research	New Orleans	Louisiana
United States	DelRicht Research	New Orleans	Louisiana
United States	New York Neurology Associates	New York	New York
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	Collective Medical Research	Overland Park	Kansas
United States	Rochester Medical Group	Rochester Hills	Michigan
United States	StudyMetrix Research	Saint Peters	Missouri
United States	WR-Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	DM Clinical Research - Detroit	Southfield	Michigan
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
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,  France,  Germany,  Italy,  Mexico,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Migraine headache pain relief will be assessed using the percentage of subjects with a headache pain intensity of none or mild. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).	2 hours post-dose

External Links

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