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New migraine pill offers hope for those who Can't take triptans

NCT ID NCT05509400

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether rimegepant, a dissolvable tablet, can relieve migraine pain in adults who cannot take triptans due to side effects, lack of effectiveness, or heart problems. Over 800 participants took either rimegepant or a placebo during a migraine attack. The main goal was to see if more people felt pain relief within 2 hours compared to 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 on the tongue)
What this could lead to
If successful, this could provide a new, effective option for people with migraine who cannot use triptans.
What could go wrong
This is a completed Phase 4 trial, so results are already in. However, the benefit may be modest, and not everyone will respond. Side effects are possible, though rimegepant is generally well-tolerated.

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

813 people

The number who actually took part.

Started

Oct 2022

Finished

Jun 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: * 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

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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, G2J 0C4, Canada

  • AOU Luigi Vanvitelli

    Naples, Naples, 80138, Italy

  • AOU Policlinico di Modena

    Modena, 41124, Italy

  • Aggarwal and Associates Limited

    Brampton, Ontario, L6T 0G1, Canada

  • Akardo MedSite

    Stockholm, 117 27, Sweden

  • Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • Alpha Recherche Clinique

    Québec, Quebec, G3K 2P8, Canada

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • CHU Clermont Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, 63000, France

  • CHU Nice Hopital Cimiez

    Nice, 06000, France

  • CHU Saint-Etienne - Hopital Nord

    Saint-Etienne, 42055, France

  • CHU de Lille - Hôpital Salengro

    Lille, 59037, France

  • CTC Solna

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

  • CTC Uppsala

    Uppsala, Uppsala County, 752 37, Sweden

  • Cabinet Privé Dr. Simona Sava

    Saint-Nicolas, Liège, 4420, Belgium

  • Centre Hospitalier Annecy Genevois

    Epagny Metz-Tessy, 74370, France

  • 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

  • Charité Universitätsmedizin Berlin, Neurologische Ambulanz, Kopfschmerzambulanz

    Berlin, 10117, Germany

  • Clinical Research Institute

    Los Angeles, California, 90048, United States

  • Clinical Research Institute S.C.

    Tlalnepantla, State of Mexico, 54055, Mexico

  • Clinique Neuro-Lévis

    Lévis, Quebec, G6W 0M5, Canada

  • Clinstile SA de CV

    Mexico City, CDMX 06700, Mexico

  • Clinvest Research, LLC

    Springfield, Missouri, 65807, United States

  • Collective Medical Research

    Overland Park, Kansas, 66210, United States

  • Community Clinical Research Network Inc

    Marlborough, Massachusetts, 01752, United States

  • Concept Medica

    Warsaw, Masovian Voivodeship, 00-773, Poland

  • DM Clinical Research

    Tomball, Texas, 77375, United States

  • DM Clinical Research - Detroit

    Southfield, Michigan, 48076, United States

  • DM Clinical Research - NY, NY

    Brooklyn, New York, 11220, United States

  • Danish Headache Center

    Glostrup Municipality, 2600, Denmark

  • DelRicht Research

    New Orleans, Louisiana, 70115, United States

  • Fondazione Mondino - Istituto Neurologico Nazionale IRCCS

    Pavia, 27100, Italy

  • Fondazione Policlinico Campus BioMedico

    Rome, RM, 00128, Italy

  • Foundation IRCCS Neurological Institute Carlo Besta

    Milan, 20133, Italy

  • GZA Ziekenhuizen

    Antwerp, 2610, Belgium

  • Headache Wellness Center, PC

    Greensboro, North Carolina, 27405, United States

  • Headache and Pain Unit - IRCCS San Raffaele

    Rome, 00163, Italy

  • Helsinki Headache Center

    Helsinki, Uusimaa, 00830, Finland

  • Hopital Lariboisiere

    Paris, 75010, France

  • Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer

    Bron, 69500, France

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospitalsenhed Midt

    Viborg, DK-8800, Denmark

  • Hälsoklustret

    Stockholm, 112 39, Sweden

  • IRCCS Ospedale San Raffaele

    Milan, MI, 20132, Italy

  • Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k.

    Oświęcim, Małopolska, 32-600, Poland

  • 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, WC2R 2LS, United Kingdom

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, Carinthia, 9020, Austria

  • Kopfschmerzzentrum Frankfurt

    Frankfurt, 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 University Innsbruck

    Innsbruck, Tyrol, 6020, Austria

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan, 48104, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Neurologische Praxis Prof. Dr. Hartmut Gobel

    Kiel, Schleswig-Holstein, D-24149, Germany

  • New York Neurology Associates

    New York, New York, 10003, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

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

    Mexico City, 14050, Mexico

  • Praktyka Lekarska

    Warsaw, 00-144, Poland

  • 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

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

    Ormond Beach, Florida, 32174, United States

  • Sensible Healthcare LLC

    Ocoee, Florida, 34761, United States

  • Skåneuro Privatmottagning

    Lund, 222 22, Sweden

  • St Charles Clinical Research

    Weldon Spring, Missouri, 63304, United States

  • Synexus Clinical Research US, Inc. - Anderson

    Anderson, South Carolina, 29621, United States

  • Terveystalo Pulssi

    Turku, 20100, Finland

  • Terveystalo Ruoholahti

    Helsinki, Finland

  • Terveystalo Tampere Rautatienkatu

    Tampere, 33100, Finland

  • Timone Hospital

    Marseille, Provence, 13005, France

  • Twoja Przychodnia Nowosolskie Centrum Medyczne

    Nowa Sól, Lubusz Voivodeship, 67-100, Poland

  • USC Clinical Trials Centre

    Sippy Downs, Queensland, 4556, Australia

  • UZ Brussel

    Brussels, 1090, Belgium

  • UZ Gent

    Ghent, 9000, Belgium

  • University Hospital Jena

    Jena, Thuringia, 07747, Germany

  • University Hospital Marqués de Valdecilla

    Santander, Cantabria, 39008, Spain

  • University Hospital of Southern Denmark

    Esbjerg, DK-6700, Denmark

  • University of Calgary South Health Campus

    Calgary, Alberta, T3M 1M4, Canada

  • Virgen del Rocio University Hospital

    Seville, 41013, Spain

  • Vita Longa Sp. Z o.o.

    Katowice, 40-748, Poland

  • WR-Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia, 30328, United States

  • Wr-Msra, Llc

    Lake City, Florida, 32055, United States

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