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

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.

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).

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: Rimegepant; Drug: Rimegepant; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pfizer Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Australia
  • Queensland
    • Sippy Downs, Queensland, Australia, 4556
      • Recruiting
      • USC Clinical Trials Centre
  • South Australia
    • Wayville, South Australia, Australia, 5034
      • Not yet recruiting
      • PainMedSA & CerCare Pty Ltd
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Alfred Hospital
• Austria
  • Klagenfurt am Wörthersee, Austria, 9020
    • Not yet recruiting
    • Klinikum Klagenfurt am Wörthersee
  • Vienna, Austria, 1090
    • Not yet recruiting
    • Medical University of Vienna
  • Carinthia
    • Klagenfurt am Wörthersee, Carinthia, Austria, 9020
      • Recruiting
      • Klinikum Klagenfurt am Wörthersee
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Recruiting
      • Medical University Innsbruck
• Belgium
  • Antwerpen, Belgium, 2610
    • Recruiting
    • GZA Ziekenhuizen
  • Brussels, Belgium, 1090
    • Recruiting
    • UZ Brussel
  • Gent, Belgium, 9000
    • Not yet recruiting
    • UZ Gent
  • Hasselt, Belgium, 3500
    • Not yet recruiting
    • Jessa Ziekenhuis
  • Saint Nicolas Province De Liège, Belgium, 4420
    • Not yet recruiting
    • Cabinet Privé Dr. Simona Sava
  • Liège
    • Saint Nicolas, Liège, Belgium, 4420
      • Recruiting
      • Cabinet Privé Dr. Simona Sava
• Canada
  • Quebec, Canada, G3K 2P8
    • Recruiting
    • Alpha Recherche Clinique
  • Quebec, Canada, G2J 0C4
    • Recruiting
    • Alpha Recherche Clinique
  • Alberta
    • Calgary, Alberta, Canada, T3M 1M4
      • Recruiting
      • University of Calgary South Health Campus
  • Ontario
    • Brampton, Ontario, Canada, L6V 1C2
      • Not yet recruiting
      • NeuPath Centre for Pain and Spine
  • Quebec
    • Levis, Quebec, Canada, G6W 0M5
      • Recruiting
      • Clinique Neuro-Lévis
• Denmark
  • Copenhagen, Denmark, 2400
    • Not yet recruiting
    • Bispebjerg Hospital
  • Glostrup, Denmark, 2600
    • Recruiting
    • Danish Headache Center
  • Capital Region
    • Copenhagen NV, Capital Region, Denmark, 2400
      • Not yet recruiting
      • Bispebjerg Hospital
• Finland
  • Helsinki, Finland
    • Recruiting
    • Terveystalo Ruoholahti
  • Turku, Finland, 20100
    • Recruiting
    • Terveystalo Pulssi
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 830
      • Not yet recruiting
      • Helsinki Headache Center
    • Helsinki, Uusimaa, Finland, 00830
      • Terminated
      • Helsinki Headache Center
• France
  • Bron, France, 69677
    • Not yet recruiting
    • CHU Lyon Hôpital Pierre Wertheimer
  • Bron, France, 69500
    • Recruiting
    • Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU Clermont Ferrand - Hopital Gabriel Montpied
  • Epagny Metz-Tessy, France, 74370
    • Recruiting
    • Centre Hospitalier Annecy Genevois
  • Lille, France, 59037
    • Recruiting
    • CHU de Lille - Hôpital Salengro
  • Marseille, France, 13005
    • Not yet recruiting
    • Timone Hospital
  • Nice, France, 06000
    • Recruiting
    • CHU Nice Hopital Cimiez
  • Paris, France, 75010
    • Recruiting
    • Hopital Lariboisiere
  • Saint-Etienne Cedex 2, France, 42055
    • Recruiting
    • CHU Saint-Etienne - Hopital Nord
  • Haute-savoie
    • Epagny Metz-Tessy, Haute-savoie, France, 74370
      • Not yet recruiting
      • Centre Hospitalier Annecy Genevois
  • Loire
    • Saint Priest en Jarez, Loire, France, 42270
      • Not yet recruiting
      • CHU Saint-Etienne, Hopital Nord
  • Provence
    • Marseille, Provence, France, 13005
      • Recruiting
      • Timone Hospital
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité Universitätsmedizin Berlin, Neurologische Ambulanz, Kopfschmerzambulanz
  • Frankfurt, Germany, 65929
    • Recruiting
    • Kopfschmerzzentrum Frankfurt
  • Greifswald, Germany, 17475
    • Not yet recruiting
    • Universitätsmedizin Greifswald
  • Jena, Germany, 07747
    • Not yet recruiting
    • University Hospital Jena
  • Kiel, Germany, 24149
    • Not yet recruiting
    • Schmerzklinik Kiel
  • Kiel, Germany, 24194
    • Not yet recruiting
    • Neurologische Praxis Prof. Dr. Hartmut Gobel
  • Wiesbaden, Germany, 65191
    • Not yet recruiting
    • Helios DKD Hospital Wiesbaden
  • Hessen
    • Kassel, Hessen, Germany, 34131
      • Not yet recruiting
      • Vitos Orthopaedische Klinik Kassel
  • Mecklenburg-vorpommern
    • Greifswald, Mecklenburg-vorpommern, Germany, 17475
      • Not yet recruiting
      • Universitätsmedizin Greifswald
  • Schleswig-holstein
    • Kiel, Schleswig-holstein, Germany, D-24149
      • Recruiting
      • Neurologische Praxis Prof. Dr. Hartmut Gobel
  • Thüringen
    • Jena, Thüringen, Germany, 07747
      • Not yet recruiting
      • University Hospital Jena
• Italy
  • Milano, Italy, 20133
    • Not yet recruiting
    • Foundation IRCCS Neurological Institute Carlo Besta
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione Mondino - Istituto Neurologico Nazionale IRCCS
  • Rome, Italy, 00163
    • Recruiting
    • Headache and Pain Unit - IRCCS San Raffaele
  • MI
    • Milano, MI, Italy, 20132
      • Not yet recruiting
      • IRCCS Ospedale San Raffaele
  • Naples
    • Napoli, Naples, Italy, 80138
      • Recruiting
      • AOU Luigi Vanvitelli
  • Rome
    • Roma, Rome, Italy, 00163
      • Not yet recruiting
      • IRCCS San Raffaele Roma
• Mexico
  • Aguascalientes, Mexico, 20116
    • Recruiting
    • Centro de Investigación Médica de Aguascalientes (CIMA)
  • Mexico City, Mexico, CDMX 06700
    • Not yet recruiting
    • Clinstile SA de CV
  • Mexico City, Mexico, CDMX 14050
    • Not yet recruiting
    • Unidad de Investigación En Salud de Chihuahua Sc
  • Estado DE Mexico
    • Tlalnepantla de Baz, Estado DE Mexico, Mexico, 54055
      • Recruiting
      • Clinical Research Institute S.C.
• Poland
  • Katowice, Poland, 40-748
    • Recruiting
    • Vita Longa Sp. z o.o.
  • Szczecin, Poland, 70-784
    • Recruiting
    • MICS Centrum Medyczne Szczecin
  • Warszawa, Poland, 00-144
    • Recruiting
    • Praktyka Lekarska
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-163
      • Not yet recruiting
      • Centrum Medyczne Neuromed
  • Lubuskie
    • Nowa Sol, Lubuskie, Poland, 67-100
      • Not yet recruiting
      • Twoja Przychodnia Nowosolskie Centrum Medyczne
    • Nowa Sol, Lubuskie, Poland, 67-100
      • Recruiting
      • Twoja Przychodnia Nowosolskie Centrum Medyczne
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 00-773
      • Recruiting
      • Concept Medica
    • Warszawa, Mazowieckie, Poland, 02-739
      • Not yet recruiting
      • MICS Centrum Medyczne Damiana Walbrzyska
  • Małopolska
    • Oświęcim, Małopolska, Poland, 32-600
      • Not yet recruiting
      • Instytut Zdrowia
    • Oświęcim, Małopolska, Poland, 32-600
      • Recruiting
      • Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k.
  • Łódzkie
    • Łódź, Łódzkie, Poland, 91-363
      • Recruiting
      • Centrum Leczenia Bolu dr n med Lukasz Kmieciak
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08035
    • Not yet recruiting
    • Hospital Universitario Vall d'Hebron
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
  • Sevilla, Spain, 41013
    • Not yet recruiting
    • Virgen del Rocio University Hospital
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clínico Universitario de Valencia
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • University Hospital Marqués de Valdecilla
    • Santander, Cantabria, Spain, 39008
      • Not yet recruiting
      • University Hospital Marqués de Valdecilla
• Sweden
  • Lund, Sweden, 222 22
    • Recruiting
    • Skåneuro Privatmottagning
  • Solna Stockholm, Sweden, 171 64
    • Not yet recruiting
    • CTC AB
  • Stockholm, Sweden, 112 39
    • Recruiting
    • Hälsoklustret
  • Stockholm, Sweden, 117 27
    • Recruiting
    • Akardo MedSite
  • Uppsala, Sweden, 752 37
    • Not yet recruiting
    • CTC Uppsala
  • Stockholms LÄN [se-01]
    • Solna, Stockholms LÄN [se-01], Sweden, 171 64
      • Recruiting
      • CTC Solna
  • Uppsala LÄN
    • Uppsala, Uppsala LÄN, Sweden, 752 37
      • Not yet recruiting
      • CTC Uppsala
• United Kingdom
  • Swinton, Manchester, United Kingdom, M27 8FF
    • Recruiting
    • 4 Medical Clinical Solutions
  • Birmingham
    • Edgebaston, Birmingham, United Kingdom, B16 8LT
      • Not yet recruiting
      • Re: Cognition Health Ltd.
  • Northamptonshire
    • Corby, Northamptonshire, United Kingdom, NN17 2UR
      • Not yet recruiting
      • Lakeside Healthcare Group Research
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Not yet recruiting
      • Oxford University Hospitals NHS Foundation Trust
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Clinical Research Institute
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Recruiting
      • Ki Health Partners LLC, dba New England Institute for Clinical Research
      • Contact: Valerija Misev; Phone Number: 125 203-914-1903; Email: valerija@neinh.com
  • Florida
    • Edgewater, Florida, United States, 32132
      • Not yet recruiting
      • Complete Health Research
    • Edgewater, Florida, United States, 32132
      • Not yet recruiting
      • Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit
    • Lake City, Florida, United States, 32055
      • Recruiting
      • Wr-Msra, Llc
    • Miami, Florida, United States, 33126
      • Recruiting
      • AppleMed Research Group, LLC
    • Ocoee, Florida, United States, 34761
      • Not yet recruiting
      • Sensible Healthcare LLC
    • Ormond Beach, Florida, United States, 32174
      • Recruiting
      • Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Active, not recruiting
      • WR-Mount Vernon Clinical Research, LLC
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Recruiting
      • Collective Medical Research
      • Contact: Kayla Clemens; Phone Number: 913-381-7180; Email: kclemens@cmr-kc.com
  • Louisiana
    • New Orleans, Louisiana, United States, 70124
      • Recruiting
      • DelRicht Research
    • New Orleans, Louisiana, United States, 70115
      • Recruiting
      • DelRicht Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Recruiting
      • Boston Clinical Trials
    • Marlborough, Massachusetts, United States, 01752
      • Recruiting
      • Community Clinical Research Network Inc
  • Michigan
    • Southfield, Michigan, United States, 48076
      • Not yet recruiting
      • DM Clinical Research - Detroit, MI
  • Missouri
    • Saint Peters, Missouri, United States, 63303
      • Not yet recruiting
      • StudyMetrix Research
    • Springfield, Missouri, United States, 65807
      • Recruiting
      • Clinvest Research, LLC
    • Springfield, Missouri, United States, 65810
      • Recruiting
      • Clinvest Research, LLC
    • Weldon Spring, Missouri, United States, 63304
      • Recruiting
      • St Charles Clinical Research
    • Weldon Spring, Missouri, United States, 63304
      • Not yet recruiting
      • St Charles Clinical Research
  • New York
    • Bronx, New York, United States, 10461
      • Recruiting
      • Montefiore Medical Center
    • Brooklyn, New York, United States, 11220
      • Not yet recruiting
      • DM Clinical Research - NY, NY
    • New York, New York, United States, 10003
      • Recruiting
      • New York Neurology Associates
    • North Massapequa, New York, United States, 11758-1853
      • Not yet recruiting
      • DiGiovanna Institute for Medical Education And Research
  • North Carolina
    • Greensboro, North Carolina, United States, 27405
      • Recruiting
      • Headache Wellness Center, PC
  • Texas
    • Lake Jackson, Texas, United States, 77566
      • Recruiting
      • Red Star Research, LLC
    • Tomball, Texas, United States, 77375
      • Recruiting
      • DM Clinical Research
      • Contact: Martha Juarez; Phone Number: 281-517-0550; Email: martha.juarez@dmclinical.com
  • Washington
    • Bellevue, Washington, United States, 98007
      • Recruiting
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rimegepant; Rimegepant - Double-blind (DB) Phase: One dose of rimegepant 75 mg Oral Disintegrating Tablet (ODT) Rimegepant/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT as needed for a qualifying acute migraine. A qualifying migraine is an attack of moderate or severe headache pain intensity. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe)	Drug: Rimegepant; DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT); Drug: Rimegepant; OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines
Placebo Comparator: Placebo; Placebo - Double-blind (DB) Phase: One dose of matching placebo Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine	Drug: Rimegepant; DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT); Drug: Rimegepant; OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines; Drug: Placebo; DB Phase: matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Estimated): November 12, 2024
• Study Completion (Estimated): February 18, 2025

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Estimated): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Migraine; Headache; Acute Migraine; Acute treatment of Migraine in adults unsuitable for triptans
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: BHV3000-406; 2022-001175-14 (Registry Identifier: CTIS (EU)); C4951004 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No