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New hope for migraine sufferers: rimegepant shows promise in prevention trial

NCT ID NCT05518123

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed phase 4 study tested whether rimegepant, a dissolvable tablet taken every other day, can prevent migraines in adults who did not get enough relief from other oral preventive medications. Over 960 participants were enrolled. The main goal was to see if rimegepant reduces the number of migraine days per month compared to a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rimegepant (a pill that dissolves in the mouth, taken every other day)
What this could lead to
If successful, this could offer a new preventive option for people with migraines who haven't been helped by existing oral medications.
What could go wrong
This is a phase 4 study, so the drug is already approved; however, it may not work for everyone, and side effects or lack of benefit are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

962 people

The number who actually took part.

Started

Nov 2022

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 first 28- days of the 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.

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Conditions

The condition(s) this trial relates to.

Headache migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

Contacts and locations

Locations

  • 4 Medical Clinical Solutions

    Swinton, M27 8FF, United Kingdom

  • 4 Medical Clinical Solutions London

    Ilford, Essex, IG1 4HP, United Kingdom

  • ALPHA Recherche Clinique

    Québec, Quebec, G3K 2P8, Canada

  • ALPHA Recherche Clinique

    Québec, G2J 0C4, Canada

  • AOU Luigi Vanvitelli

    Naples, Naples, 80134, Italy

  • AZ Sint-Jan Brugge-Oostende AV

    Bruges, 8000, Belgium

  • Aggarwal and Associates Limited

    Brampton, Ontario, L6T 0G1, Canada

  • Akardo Med Site

    Stockholm, 117 27, Sweden

  • Albuquerque Clinical Trials. Inc.

    Albuquerque, New Mexico, 87102, United States

  • Alliance for Multispecialty Reseach, LLC

    Knoxville, Tennessee, 37909, United States

  • AppleMed Research Group, LLC

    Miami, Florida, 33126, United States

  • Bispebjerg Hospital

    Copenhagen NV, Capital Region, 2400, Denmark

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • CTC MTC

    Uppsala, Uppsala LÄN [se-03], 752 37, Sweden

  • CTC Solna

    Solna, Stockholms LÄN [se-01], 171 64, Sweden

  • Cabinet Privé Dr. Simona Sava

    Saint Nicolas Province de Liège, 4420, Belgium

  • California Neuroscience Research, LLC

    Sherman Oaks, California, 91403, United States

  • Carlanderska Hospital

    Gothenburg, 40545, Sweden

  • Centermed Kraków Sp. Z o.o.

    Krakow, Malopolska, 31-530, Poland

  • Centre de Recherche Saint-Louis/Clinique Neuro-Levis

    Lévis, Quebec, G6W0M5, Canada

  • Centro de Investigación Médica de Aguascalientes (CIMA)

    Aguascalientes, 20116, Mexico

  • Centrum Leczenia Bolu dr n med Lukasz Kmieciak

    Lodz, Łódź Voivodeship, 91-363, Poland

  • Centrum Medyczne Neuromed

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland

  • Centrum Medyczne OPOROW

    Wroclaw, 52-416, Poland

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081, Poland

  • Clinical Research Institute

    Los Angeles, California, 90048, United States

  • Clinical Research Institute S.C.

    Tlalnepantla, State of Mexico, C.P. 54055, Mexico

  • Clinique de la Citadelle

    Liège, 4000, Belgium

  • Clinstile, SA de CV

    Mexico City, CDMX 06700, Mexico

  • Clinvest Research, LLC

    Springfield, Missouri, 65807, United States

  • Cognition Health - Bristol

    Bristol, BS32 4SY, United Kingdom

  • Community Clinical Research Network, Inc.

    Marlborough, Massachusetts, 01752, United States

  • Concept Medica

    Warsaw, Masovian Voivodeship, 00-773, Poland

  • Consorcio Hospital General Universitario

    Valencia, 46014, Spain

  • DM Clinical Research

    Tomball, Texas, 77375, United States

  • Danish Headache Center

    Glostrup Municipality, Capital Region, 2600, Denmark

  • DiGiovanna Institute for Medical Education And Research

    North Massapequa, New York, 11758, United States

  • Dr Sekowska Leczenie Bolu

    Warsaw, Masovian Voivodeship, 01-018, Poland

  • GZA Ziekenhuizen

    Antwerp, 2610, Belgium

  • Headache Wellness Center, PC

    Greensboro, North Carolina, 27405, United States

  • Hospital Clinic de Barcelona Plato Headquarters

    Barcelona, 08006, Spain

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47010, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Ruber Juan Bravo

    Salamanca, 28006, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario de Elda

    Elda, Alicante, 03600, Spain

  • Hospital Universitario de La Princesa

    Madrid, 28006, Spain

  • Hospitalsenhed Midt

    Viborg, DK-8800, Denmark

  • Hull University Hospitals NHS Trust

    Hull, EAST Riding, HU3 2JZ, United Kingdom

  • Hälsoklustret

    Stockholm, 112 39, Sweden

  • IRCCS Fondazione Besta

    Milan, 20133, Italy

  • IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino

    Pavia, Lombardy, 27100, Italy

  • IRCCS Ospedale San Raffaele

    Milan, MI, 20132, Italy

  • IRCCS San Raffaele

    Rome, Rome/lazio, 00163, Italy

  • Instytut Zdrowia

    Oświęcim, Małopolska, 32-600, Poland

  • Intermed GmbH

    Wiesbaden, Hesse, 65189, Germany

  • James Paget University Hospitals NHS Foundation Trust

    Great Yarmouth, Norfolk, NR31 6LA, United Kingdom

  • Jessa Ziekenhuis

    Hasselt, 3500, Belgium

  • Ki Health Partners LLC, dba New England Institute for Clinical Research

    Stamford, Connecticut, 06905, United States

  • Kings College London

    London, SE5 9PJ, United Kingdom

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020, Austria

  • Kopfschmerzzentrum Frankfurt

    Frankfurt am Main, Hesse, 65929, Germany

  • Lakeside Healthcare Group Research

    Corby, Northamptonshire, NN17 2UR, United Kingdom

  • MICS Centrum Medyczne Damiana Walbrzyska

    Warsaw, Masovian Voivodeship, 02-739, Poland

  • MICS Centrum Medyczne Szczecin

    Szczecin, 70-784, Poland

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, Lower Silesian Voivodeship, 52-210, Poland

  • MTZ Clinical Research Powered by Pratia

    Warsaw, 02-172, Poland

  • Medical Care and Research S.A. de C.V.

    Mérida, Yucatán, CP. 97070, Mexico

  • Medical University Innsbruck

    Innsbruck, Tyrol, 6020, Austria

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan, 48104, United States

  • NeuPath Centre for Pain and Spine

    Brampton, Ontario, L6V 1C2, Canada

  • Neuropoint GmbH

    Ulm Baden-Wuerttemberg, 89073, Germany

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv

    Mexico City, CP 14050, Mexico

  • Phylasis Clinicas Research S. de R.L. de C.V.

    Cuautitlán Izcalli, State of Mexico, 54769, Mexico

  • Premium Clinic Wrocław

    Wroclaw, 50-414, Poland

  • Queen Elizabeth University Hospital

    Glasgow, Scotland, G51 4TF, United Kingdom

  • Re: Cognition Health Ltd.

    Edgebaston, Birmingham, B16 8LT, United Kingdom

  • Red Star Research, LLC

    Lake Jackson, Texas, 77566, United States

  • Rochester Medical Group

    Rochester Hills, Michigan, 48307, United States

  • SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi

    Florence, 50134, Italy

  • Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit

    Ormond Beach, Florida, 32174, United States

  • Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit

    Edgewater, Florida, 32132, United States

  • Schmerz- und Palliativzentrum Göppingen

    Göppingen, Baden-Wurttemberg, 73033, Germany

  • Sensible Healthcare LLC

    Ocoee, Florida, 34761, United States

  • Skåneuro Privatmottagning

    Lund, 222 22, Sweden

  • St Charles Clinical Research

    Weldon Spring, Missouri, 63304, United States

  • Studienzentrum Nordwest

    Westerstede, Lower Saxony, 26655, Germany

  • Synexus - Prüfzentrum Berlin

    Berlin, 12672, Germany

  • Synexus - Prüfzentrum Leipzig

    Leipzig, Saxony, 04103, Germany

  • Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre

    Frankfurt am Main, Hesse, 60313, Germany

  • Synexus Clinical Research US, Inc. - Anderson

    Anderson, South Carolina, 29621, United States

  • Terveystalo Pulssi

    Turku, 20100, Finland

  • Terveystalo Ruoholahti

    Helsinki, Uusimaa, 00180, Finland

  • Terveystalo Tampere

    Tampere, 33100, Finland

  • Twoja Przychodnia Nowosolskie Centrum Medyczne

    Nowa Sól, Lubusz Voivodeship, 67-100, Poland

  • USC Clinical Trials Sunshine Coast

    Sippy Downs, Queensland, 4556, Australia

  • UZ Brussel

    Jette, Brussels Capital, 1090, Belgium

  • University Hospital Marqués de Valdecilla

    Santander, 39008, Spain

  • University Hospital Uppsala (VO Neuro)

    Uppsala, 75185, Sweden

  • University Hospital of Southern Denmark

    Esbjerg, DK-6700, Denmark

  • University Modena e Reggio Emilia

    Modena, 41124, Italy

  • Virgen del Rocio University Hospital

    Seville, 41013, Spain

  • Vita Longa Sp. Z o.o.

    Katowice, 40-748, Poland

  • Wr-Crcn, Llc

    Las Vegas, Nevada, 89118, United States

  • Wr-Msra,Llc

    Lake City, Florida, 32055, United States

  • Zentrum für klinische Forschung

    Bad Homburg, Hesse, 61350, Germany

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Other studies related to the condition(s) this trial covers.