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New hope for teens with chronic migraines: rimegepant trial begins

NCT ID NCT06616194

Prevention 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 31, 2026 · Updated 4 times

Summary

This study tests whether the medicine rimegepant can prevent migraines in teenagers aged 12 to 17 who have frequent, long-lasting headaches. About 200 teens will take either rimegepant or a placebo every other day for 3 months, then all will receive rimegepant for a year. The goal is to see if the medicine reduces the number of migraine days per month and is safe for long-term use.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Oct 2029

An estimate. End dates often move.

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

12 to 17 years

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: * At least a 6 month history of migraine (with or without aura) * 15 or more headache days/month * 8 or more migraine days/month * Migraine lasting 4-72 hours if untreated Exclusion Criteria: * Unrelenting headache * Current psychiatric condition uncontrolled or untreated * History of suicidal behavior or the subject is at risk of self-harm * History of alcohol abuse and/or illicit drug use * History of severe drug allergy * Use of more than one medication for migraine prevention/prophylaxis * Participation in another clinical trial at the same time

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

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

Migraine

Contacts and locations

Locations

  • ASL1 Avezzano-Sulmona-L'Aquila

    L’Aquila, Abruzzo, 67100, Italy

  • Adult & Child Neurology Medical Associates

    Long Beach, California, 90806, United States

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001, China

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Anhui Provincial Hospital

    Hefei, 230001, China

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Artemis hospital

    Gurugram, Haryana, 122001, India

  • Asst Spedali Civili Di Brescia

    Brescia, 25123, Italy

  • AthleticoMed

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752, Poland

  • Avera Medical Group Pediatric Specialists

    Sioux Falls, South Dakota, 57105, United States

  • Avera Medical Group Pediatrics - Dawley Farm

    Sioux Falls, South Dakota, 57110, United States

  • Avera Research Institute - Sioux Falls

    Sioux Falls, South Dakota, 57108, United States

  • CHUVI- Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36213, Spain

  • CaRe Clinic

    Red Deer, Alberta, T4P 1K4, Canada

  • Centrum Medyczne Hope Clinic Sebastian Szklener

    Lublin, Lublin Voivodeship, 20-701, Poland

  • Chicago Headache Center and Research Institute

    Chicago, Illinois, 60657, United States

  • Chicago Headache Center and Research Institute

    Naperville, Illinois, 60563, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Chopda Medicare & Research Centre Pvt. Ltd; Magnum Heart Institute

    Nashik, Maharashtra, 422005, India

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinical Research Institute Helsinki University Central Hospital Ltd

    Helsinki, 00280, Finland

  • Clinvest Headlands Llc

    Springfield, Missouri, 65807, United States

  • Dell Children's Medical Center

    Austin, Texas, 78723, United States

  • Detska fakultna nemocnica s poliklinikou Banska Bystrica

    Banská Bystrica, 97409, Slovakia

  • Detska nemocnice FN Brno

    Brno, Brno-město, 613 00, Czechia

  • Dr Sękowska Leczenie Bólu

    Warsaw, Masovian Voivodeship, 01-018, Poland

  • Dr. Kenessey Albert Kórház

    Balassagyarmat, Nógrád megye, 2660, Hungary

  • Duke Children's Health Center

    Durham, North Carolina, 27710, United States

  • Duke Health Center Creekstone

    Durham, North Carolina, 27703, United States

  • Duke Lenox Baker Children's

    Durham, North Carolina, 27705, United States

  • Fakultni Nemocnice Motol a Homolka

    Prague, 150 06, Czechia

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4, 14059, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Ostrava

    Ostrava, Moravian-Silesian Region, 708 52, Czechia

  • Fondazione Istituto Neurologico C. Mondino

    Pavia, 27100, Italy

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004, China

  • Granger Medical Holladay - Holladay Clinic

    Salt Lake City, Utah, 84117, United States

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180, China

  • Headlands Research-El Paso

    El Paso, Texas, 79902, United States

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47005, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario HM Puerta del Sur

    Madrid, Madrid, Comunidad de, 28938, Spain

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • I.C.O.T. Università La Sapienza

    Latina, 04100, Italy

  • IN MEDIC s.r.o.

    Bardejov, Slovakia

  • IRCCS Istituto Neurologico Carlo Besta

    Milan, Lombardy, 20133, Italy

  • IRCCS San Raffaele Roma

    Rome, ROMA, 00163, Italy

  • IRCCS San Raffaele Roma

    Roma, 00166, Italy

  • Jingzhou First People's Hospital

    Jingzhou, Hubei, 434000, China

  • KONZILIUM s.r.o.

    Dubnica nad Váhom, Slovakia

  • Konan Medical Center

    Kobe, Hyōgo, 658-0064, Japan

  • Kuopion Yliopistollinen Sairaala

    Kuopio, Northern Savonia, 70210, Finland

  • London Health Sciences Centre - Verspeeten Family Cancer Centre

    London, Ontario, N6A 5W9, Canada

  • MIGRE Polskie Centrum Leczenia Migreny

    Wroclaw, Lower Silesian Voivodeship, 52-210, Poland

  • Mallikatta Neuro Centre

    Mangalore, Karnataka, 575002, India

  • MedicArt Sp. z o. o.

    Wroclaw, Lower Silesian Voivodeship, 53-025, Poland

  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

    Warsaw, Masovian Voivodeship, 04-501, Poland

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan, 48104, United States

  • NZOZ Neuromed M. i M. Nastaj Sp. P.

    Lublin, 20-064, Poland

  • Nagaseki Headache Clinic

    Kai, Yamanashi, 400-0124, Japan

  • Nagykanizsai Kanizsai Dorottya Korhaz

    Nagykanizsa, Zala County, 8800, Hungary

  • Neurosphera

    Warsaw, Masovian Voivodeship, 02-829, Poland

  • New Children's Hospital

    Helsinki, 00290, Finland

  • New England Regional Headache Center

    Worcester, Massachusetts, 01609, United States

  • OnSite Clinical Solutions

    Charlotte, North Carolina, 28211, United States

  • Ospedale San Paolo Bari

    Bari, Apulia, 70132, Italy

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

  • Rutgers University

    New Brunswick, New Jersey, 08901, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Semmelweis Egyetem

    Budapest, 1094, Hungary

  • Shanghai Children's Hospital

    Shanghai, 200062, China

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060, India

  • Specjalistyczne Gabinety Sp. z o.o.

    Krakow, Lesser Poland Voivodeship, 30-539, Poland

  • Stollery Children's Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa, 33520, Finland

  • Tanaka Neurosurgery&Headache Clinic

    Kagoshima, 890-0052, Japan

  • Tennoji Department of Neurosurgery

    Osaka, 545-0053, Japan

  • Terveystalo Oulu

    Oulu, North Ostrobothnia, 90100, Finland

  • Terveystalo Pulssi

    Turku, 20100, Finland

  • Terveystalo Tampere

    Tampere, 33100, Finland

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The Second Affiliated Hospital of Hebei Medical University

    Shijiazhuang, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013, China

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • Tokyo Headache Clinic

    Shibuya-ku, Tokyo, 151-0051, Japan

  • Tominaga Clinic

    Osaka, Osaka, 556-0015, Japan

  • Turku University Hospital

    Turku, Southwest Finland, 20520, Finland

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • University Of Alberta Hospital

    Edmonton, Alberta, T6G 1W9, Canada

  • Univerzitna nemocnica Martin

    Martin, 036 59, Slovakia

  • Wake Forest University Baptist Medical Center ( WFUBMC )

    Winston-Salem, North Carolina, 27157, United States

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107, United States

  • Wuhan Children's Hospital

    Wuhan, Hubei, 430010, China

  • Wuxi Children's Hospital

    Wuxi, Jiangsu, 214023, China

  • Xenoscience Inc

    Phoenix, Arizona, 85004, United States

  • Yamaguchi Clinic

    Nishinomiya, Hyōgo, 663-8204, Japan

More trials for these conditions

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