Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications
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
3 other identifiers
interventional
962
13 countries
109
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2022
Typical duration for phase_4
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2022
CompletedFirst Posted
Study publicly available on registry
August 26, 2022
CompletedStudy Start
First participant enrolled
November 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2025
CompletedResults Posted
Study results publicly available
May 22, 2026
CompletedMay 22, 2026
April 1, 2026
2.4 years
August 23, 2022
March 19, 2026
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
A migraine day was defined as any calendar day in which participant (1) had a qualified migraine headache or (2) took acute migraine-specific medication (i.e., triptan, ergotamine, lasmiditan, or ubrogepant) to treat headache or aura. A qualified migraine headache was defined as a migraine with or without aura, lasting for \>=30 minutes, met criteria: \>=2 of pain features: unilateral location; pulsating quality (throbbing); moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) or \>=1 of associated symptoms: nausea and/or vomiting; photophobia and phonophobia. Number of migraine days per month were prorated to 28 days.
Observation phase (28 days prior to randomization), DBT phase (through Month 3 [Week 1 to 12])
Secondary Outcomes (23)
Percentage of Participants With >= 50 Percent (%) Reduction From OP in the Number of Moderate or Severe Migraine Days (MD) Per Month Over the Entire DBT Phase (Weeks 1 to 12)
DBT phase (through Month 3 [Week 1 to 12])
Mean Change From OP in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of the DBT Phase
Observation phase (28 days prior to randomization), Week 1 to Week 4 of the DBT phase
Mean Change From OP in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of the DBT Phase
Observation phase (28 days prior to randomization), Week 9 to Week 12 of the DBT phase
Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) Version 2.1 Restrictive Role Function Domain Score at Week 12 of the DBT Phase
Baseline (Day 1) and Week 12 of the DBT phase
Mean Change From Baseline in the Migraine Interictal Burden Scale (MIBS) Score at Week 12 of the DBT Phase
Baseline (Day 1) and Week 12
- +18 more secondary outcomes
Study Arms (2)
Rimegepant 75 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Rimegepant 75 mg Oral Disintegrating Tablet (ODT) taken every other day during Double-blind Treatment (DBT) phase
Eligibility Criteria
You may qualify if:
- 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.
- 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 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.
- 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).
You may not qualify if:
- History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.
- Current medication overuse headaches.
- or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the first 28- days of the Observation Phase.
- Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across \> 4 categories of recognized, orally administered, migraine-preventive medications.
- Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \[CRPS\]).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (111)
Clinical Research Institute
Los Angeles, California, 90048, United States
California Neuroscience Research, LLC
Sherman Oaks, California, 91403, United States
Ki Health Partners LLC, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit
Edgewater, Florida, 32132, United States
Wr-Msra,Llc
Lake City, Florida, 32055, United States
AppleMed Research Group, LLC
Miami, Florida, 33126, United States
Sensible Healthcare LLC
Ocoee, Florida, 34761, United States
Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit
Ormond Beach, Florida, 32174, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Community Clinical Research Network, Inc.
Marlborough, Massachusetts, 01752, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Rochester Medical Group
Rochester Hills, Michigan, 48307, United States
Clinvest Research, LLC
Springfield, Missouri, 65807, United States
St Charles Clinical Research
Weldon Spring, Missouri, 63304, United States
Wr-Crcn, Llc
Las Vegas, Nevada, 89118, United States
Albuquerque Clinical Trials. Inc.
Albuquerque, New Mexico, 87102, United States
DiGiovanna Institute for Medical Education And Research
North Massapequa, New York, 11758, United States
Headache Wellness Center, PC
Greensboro, North Carolina, 27405, United States
Synexus Clinical Research US, Inc. - Anderson
Anderson, South Carolina, 29621, United States
Alliance for Multispecialty Reseach, LLC
Knoxville, Tennessee, 37909, United States
Red Star Research, LLC
Lake Jackson, Texas, 77566, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
USC Clinical Trials Sunshine Coast
Sippy Downs, Queensland, 4556, Australia
Medical University Innsbruck
Innsbruck, Tyrol, 6020, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020, Austria
UZ Brussel
Jette, Brussels Capital, 1090, Belgium
GZA Ziekenhuizen
Antwerp, 2610, Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges, 8000, Belgium
Jessa Ziekenhuis
Hasselt, 3500, Belgium
Clinique de la Citadelle
Liège, 4000, Belgium
Cabinet Privé Dr. Simona Sava
Saint Nicolas Province de Liège, 4420, Belgium
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1, Canada
NeuPath Centre for Pain and Spine
Brampton, Ontario, L6V 1C2, Canada
Centre de Recherche Saint-Louis/Clinique Neuro-Levis
Lévis, Quebec, G6W0M5, Canada
ALPHA Recherche Clinique
Québec, Quebec, G3K 2P8, Canada
ALPHA Recherche Clinique
Québec, G2J 0C4, Canada
Bispebjerg Hospital
Copenhagen NV, Capital Region, 2400, Denmark
Danish Headache Center
Glostrup Municipality, Capital Region, 2600, Denmark
University Hospital of Southern Denmark
Esbjerg, DK-6700, Denmark
Hospitalsenhed Midt
Viborg, DK-8800, Denmark
Terveystalo Ruoholahti
Helsinki, Uusimaa, 00180, Finland
Terveystalo Tampere
Tampere, 33100, Finland
Terveystalo Pulssi
Turku, 20100, Finland
Schmerz- und Palliativzentrum Göppingen
Göppingen, Baden-Wurttemberg, 73033, Germany
Zentrum für klinische Forschung
Bad Homburg, Hesse, 61350, Germany
Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre
Frankfurt am Main, Hesse, 60313, Germany
Kopfschmerzzentrum Frankfurt
Frankfurt am Main, Hesse, 65929, Germany
Intermed GmbH
Wiesbaden, Hesse, 65189, Germany
Studienzentrum Nordwest
Westerstede, Lower Saxony, 26655, Germany
Synexus - Prüfzentrum Leipzig
Leipzig, Saxony, 04103, Germany
Synexus - Prüfzentrum Berlin
Berlin, 12672, Germany
Neuropoint GmbH
Ulm Baden-Wuerttemberg, 89073, Germany
IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino
Pavia, Lombardy, 27100, Italy
IRCCS Ospedale San Raffaele
Milan, MI, 20132, Italy
AOU Luigi Vanvitelli
Naples, Naples, 80134, Italy
IRCCS San Raffaele
Rome, Rome/lazio, 00163, Italy
SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
Florence, 50134, Italy
IRCCS Fondazione Besta
Milan, 20133, Italy
University Modena e Reggio Emilia
Modena, 41124, Italy
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, State of Mexico, 54769, Mexico
Clinical Research Institute S.C.
Tlalnepantla, State of Mexico, C.P. 54055, Mexico
Medical Care and Research S.A. de C.V.
Mérida, Yucatán, CP. 97070, Mexico
Centro de Investigación Médica de Aguascalientes (CIMA)
Aguascalientes, 20116, Mexico
Clinstile, SA de CV
Mexico City, CDMX 06700, Mexico
Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv
Mexico City, CP 14050, Mexico
Centrum Medyczne Neuromed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
Centermed Kraków Sp. Z o.o.
Krakow, Malopolska, 31-530, Poland
Concept Medica
Warsaw, Masovian Voivodeship, 00-773, Poland
Dr Sekowska Leczenie Bolu
Warsaw, Masovian Voivodeship, 01-018, Poland
MICS Centrum Medyczne Damiana Walbrzyska
Warsaw, Masovian Voivodeship, 02-739, Poland
Instytut Zdrowia
Oświęcim, Małopolska, 32-600, Poland
Centrum Medyczne Pratia Katowice
Katowice, 40-081, Poland
Vita Longa Sp. Z o.o.
Katowice, 40-748, Poland
MICS Centrum Medyczne Szczecin
Szczecin, 70-784, Poland
MTZ Clinical Research Powered by Pratia
Warsaw, 02-172, Poland
Premium Clinic Wrocław
Wroclaw, 50-414, Poland
Centrum Medyczne OPOROW
Wroclaw, 52-416, Poland
Centrum Leczenia Bolu dr n med Lukasz Kmieciak
Lodz, Łódź Voivodeship, 91-363, Poland
Hospital Universitario de Elda
Elda, Alicante, 03600, Spain
Hospital Clinic de Barcelona Plato Headquarters
Barcelona, 08006, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Universitario Ruber Juan Bravo
Salamanca, 28006, Spain
University Hospital Marqués de Valdecilla
Santander, 39008, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Virgen del Rocio University Hospital
Seville, 41013, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Consorcio Hospital General Universitario
Valencia, 46014, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47010, Spain
CTC Solna
Solna, Stockholms LÄN [se-01], 171 64, Sweden
CTC MTC
Uppsala, Uppsala LÄN [se-03], 752 37, Sweden
Carlanderska Hospital
Gothenburg, 40545, Sweden
Skåneuro Privatmottagning
Lund, 222 22, Sweden
Hälsoklustret
Stockholm, 112 39, Sweden
Akardo Med Site
Stockholm, 117 27, Sweden
University Hospital Uppsala (VO Neuro)
Uppsala, 75185, Sweden
Re: Cognition Health Ltd.
Edgebaston, Birmingham, B16 8LT, United Kingdom
Hull University Hospitals NHS Trust
Hull, EAST Riding, HU3 2JZ, United Kingdom
4 Medical Clinical Solutions London
Ilford, Essex, IG1 4HP, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, Norfolk, NR31 6LA, United Kingdom
Lakeside Healthcare Group Research
Corby, Northamptonshire, NN17 2UR, United Kingdom
Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF, United Kingdom
Cognition Health - Bristol
Bristol, BS32 4SY, United Kingdom
Kings College London
London, SE5 9PJ, United Kingdom
4 Medical Clinical Solutions
Swinton, M27 8FF, United Kingdom
Related Publications (2)
Pozo-Rosich P, Gien Lopez JA, Lisewski P, Aslan AN, Seehra H, Thiry A, Abraham L, Ramirez LM, Fountaine R, Fullerton T. Does rimegepant prevent migraine attacks in people who have not found other treatments taken by mouth (orally) to work well? A plain language summary of clinical study findings. Pain Manag. 2026 Apr 28:1-12. doi: 10.1080/17581869.2026.2646702. Online ahead of print.
PMID: 42047365DERIVEDPozo-Rosich P, Lopez JAG, Lisewski P, Aslan AN, Seehra H, Thiry A, Abraham L, Ramirez LM, Fountaine R, Fullerton T. A phase 4, randomized, double-blind, placebo-controlled trial evaluating the efficacy and tolerability of rimegepant for the prevention of episodic migraine in adults with a history of inadequate response to traditional oral preventive medications. Cephalalgia. 2025 Nov;45(11):3331024251391378. doi: 10.1177/03331024251391378. Epub 2025 Nov 18.
PMID: 41255098DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2022
First Posted
August 26, 2022
Study Start
November 7, 2022
Primary Completion
March 31, 2025
Study Completion
July 8, 2025
Last Updated
May 22, 2026
Results First Posted
May 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.