A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Last updated: June 8, 2026
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Headaches

Pain

Oral Facial Pain

Treatment

Rimegepant

Placebo

Clinical Study ID

NCT06616194
C4951013
BHV3000-320
2023-505601-16-00
C4951013
  • Ages 12-17
  • All Genders

Study Summary

The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks.

Rimegepant is a tablet that dissolves when you put it on or under your tongue.

The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours

In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day.

Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months.

In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period.

Those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at all visits. Participants will have to complete a daily diary to record the migraine attacks.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Rimegepant
Phase: 3
Study Start date:
November 15, 2024
Estimated Completion Date:
December 02, 2027

Connect with a study center

  • Stollery Children's Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • University Of Alberta Hospital

    Edmonton, Alberta T6G 1W9
    Canada

    Active - Recruiting

  • CaRe Clinic

    Red Deer, Alberta T4P 1K4
    Canada

    Active - Recruiting

  • Stollery Children's Hospital

    Edmonton 5946768, Alberta 5883102 T6G 2B7
    Canada

    Active - Recruiting

  • London Health Sciences Centre - Verspeeten Family Cancer Centre

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Anhui Provincial Hospital

    Hefei 1808722, Anhui 1818058 230071
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing Municipality 100044
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality 400016
    China

    Active - Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510180
    China

    Active - Recruiting

  • Jingzhou First People's Hospital

    Jingzhou, Hubei 434000
    China

    Active - Recruiting

  • Wuhan Children's Hospital

    Wuhan, Hubei 430010
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Active - Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691 410011
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • Wuxi Children's Hospital

    Wuxi, Jiangsu 214023
    China

    Active - Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212001
    China

    Active - Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750004
    China

    Active - Recruiting

  • Shanghai Children's Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200040
    China

    Active - Recruiting

  • Anhui Provincial Hospital

    Hefei, 230001
    China

    Active - Recruiting

  • Shanghai Children's Hospital

    Shanghai, 200062
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Hebei Medical University

    Shijiazhuang,
    China

    Active - Recruiting

  • Detska nemocnice FN Brno

    Brno, Brno-město 613 00
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Hradec Králové 500 05
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Ostrava

    Ostrava, Moravian-Silesian Region 708 52
    Czechia

    Active - Recruiting

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4 14059
    Czechia

    Active - Recruiting

  • Fakultni Thomayerova nemocnice

    Prague 3067696, Praha 4 14059
    Czechia

    Active - Recruiting

  • Brno University Hospital

    Brno, 662 63
    Czechia

    Active - Recruiting

  • Fakultni Nemocnice Motol a Homolka

    Prague, 150 06
    Czechia

    Active - Recruiting

  • Terveystalo Oulu

    Oulu, North Ostrobothnia 90100
    Finland

    Active - Recruiting

  • Kuopion Yliopistollinen Sairaala

    Kuopio, Northern Savonia 70210
    Finland

    Active - Recruiting

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa 33520
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku, Southwest Finland 20520
    Finland

    Active - Recruiting

  • Clinical Research Institute Helsinki University Central Hospital Ltd

    Helsinki, 00280
    Finland

    Active - Recruiting

  • New Children's Hospital

    Helsinki, 00290
    Finland

    Active - Recruiting

  • Terveystalo Tampere

    Tampere, 33100
    Finland

    Active - Recruiting

  • Terveystalo Tampere

    Tampere 634963, 33100
    Finland

    Active - Recruiting

  • Terveystalo Pulssi

    Turku, 20100
    Finland

    Active - Recruiting

  • Terveystalo Pulssi

    Turku 633679, 20100
    Finland

    Active - Recruiting

  • Dr. Kenessey Albert Kórház

    Balassagyarmat, Nógrád megye 2660
    Hungary

    Active - Recruiting

  • Nagykanizsai Kanizsai Dorottya Korhaz

    Nagykanizsa, Zala County 8800
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem

    Budapest, 1083
    Hungary

    Active - Recruiting

  • Óbudai Egészségügyi Centrum

    Budapest, 1036
    Hungary

    Active - Recruiting

  • Óbudai Egészségügyi Centrum

    Budapest 3054643, 1036
    Hungary

    Active - Recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Active - Recruiting

  • Artemis hospital

    Gurugram, Haryana 122001
    India

    Active - Recruiting

  • Fortis Memorial Research Institute

    Gurugram, Haryana 122002
    India

    Active - Recruiting

  • Artemis hospital

    Gurugram 1270642, Haryana 1270260 122001
    India

    Active - Recruiting

  • Mallikatta Neuro Centre

    Mangalore, Karnataka 575002
    India

    Active - Recruiting

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

    Nashik, Maharashtra 422005
    India

    Active - Recruiting

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi 110029
    India

    Active - Recruiting

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi 110060
    India

    Active - Recruiting

  • Sir Ganga Ram Hospital

    New Delhi 1261481, National Capital Territory of Delhi 1273293 110060
    India

    Active - Recruiting

  • ASL1 Avezzano-Sulmona-L'Aquila

    L’Aquila, Abruzzo 67100
    Italy

    Active - Recruiting

  • Ospedale San Paolo Bari

    Bari, Apulia 70132
    Italy

    Active - Recruiting

  • AOU Policlinico Umberto I

    Roma, Lazio 00161
    Italy

    Active - Recruiting

  • AOU Policlinico Umberto I

    Rome, Lazio 00161
    Italy

    Active - Recruiting

  • IRCCS Istituto Neurologico Carlo Besta

    Milan, Lombardy 20133
    Italy

    Active - Recruiting

  • IRCCS San Raffaele Roma

    Rome, ROMA 00163
    Italy

    Site Not Available

  • Asst Spedali Civili Di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • I.C.O.T. Università La Sapienza

    Latina, 04100
    Italy

    Active - Recruiting

  • Fondazione Istituto Neurologico C. Mondino

    Pavia, 27100
    Italy

    Active - Recruiting

  • IRCCS San Raffaele Roma

    Roma, 00166
    Italy

    Site Not Available

  • Konan Medical Center

    Kobe, Hyōgo 658-0064
    Japan

    Active - Recruiting

  • Yamaguchi Clinic

    Nishinomiya, Hyōgo 663-8204
    Japan

    Active - Recruiting

  • Tominaga Clinic

    Osaka, Osaka 556-0015
    Japan

    Active - Recruiting

  • Tominaga Clinic

    Osaka 1853909, Osaka 1853904 556-0015
    Japan

    Active - Recruiting

  • Tokyo Headache Clinic

    Shibuya-ku, Tokyo 151-0051
    Japan

    Active - Recruiting

  • Nagaseki Headache Clinic

    Kai, Yamanashi 400-0124
    Japan

    Active - Recruiting

  • Tanaka Neurosurgery&Headache Clinic

    Kagoshima, 890-0052
    Japan

    Active - Recruiting

  • Tanaka Neurosurgical Clinic

    Kagoshima, 892-0844
    Japan

    Active - Recruiting

  • Tennoji Department of Neurosurgery

    Osaka, 545-0053
    Japan

    Active - Recruiting

  • AthleticoMed

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-752
    Poland

    Active - Recruiting

  • Specjalistyczne Gabinety Sp. z o.o.

    Krakow, Lesser Poland Voivodeship 30-539
    Poland

    Active - Recruiting

  • MIGRE Polskie Centrum Leczenia Migreny

    Wroclaw, Lower Silesian Voivodeship 52-210
    Poland

    Active - Recruiting

  • MedicArt Sp. z o. o.

    Wroclaw, Lower Silesian Voivodeship 53-025
    Poland

    Active - Recruiting

  • MIGRE Polskie Centrum Leczenia Migreny

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 52-210
    Poland

    Active - Recruiting

  • Centrum Medyczne Hope Clinic Sebastian Szklener

    Lublin, Lublin Voivodeship 20-701
    Poland

    Active - Recruiting

  • NZOZ Neuromed M.i M. Nastaj

    Lublin, Lublin Voivodeship 20-064
    Poland

    Site Not Available

  • Centrum Medyczne Hope Clinic Sebastian Szklener

    Lublin 765876, Lublin Voivodeship 858785 20-701
    Poland

    Active - Recruiting

  • Dr Sękowska Leczenie Bólu

    Warsaw, Masovian Voivodeship 01-018
    Poland

    Active - Recruiting

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

    Warsaw, Masovian Voivodeship 04-501
    Poland

    Active - Recruiting

  • Neurosphera

    Warsaw, Masovian Voivodeship 02-829
    Poland

    Active - Recruiting

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

    Warsaw 756135, Masovian Voivodeship 858787 04-501
    Poland

    Active - Recruiting

  • Neurosphera

    Warsaw 756135, Masovian Voivodeship 858787 02-829
    Poland

    Active - Recruiting

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

    Lublin, 20-064
    Poland

    Active - Recruiting

  • Detska fakultna nemocnica s poliklinikou Banska Bystrica

    Banská Bystrica, 97409
    Slovakia

    Active - Recruiting

  • IN MEDIC s.r.o.

    Bardejov,
    Slovakia

    Active - Recruiting

  • Detsky neurolog s.r.o.

    Bratislava, 841 03
    Slovakia

    Active - Recruiting

  • Narodny ustav detskych chorob

    Bratislava 3060972, 833 40
    Slovakia

    Active - Recruiting

  • KONZILIUM s.r.o.

    Dubnica nad Váhom,
    Slovakia

    Active - Recruiting

  • Univerzitna nemocnica Martin

    Martin, 036 59
    Slovakia

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona] 08035
    Spain

    Active - Recruiting

  • Hospital Universitario HM Puerta del Sur

    Madrid, Madrid, Comunidad de 28938
    Spain

    Active - Recruiting

  • CHUVI- Hospital Alvaro Cunqueiro

    Vigo, Pontevedra 36213
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid 3117735, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47005
    Spain

    Active - Recruiting

  • Xenoscience Inc

    Phoenix, Arizona 85004
    United States

    Active - Recruiting

  • Adult & Child Neurology Medical Associates

    Long Beach, California 90806
    United States

    Active - Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

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

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Chicago Headache Center and Research Institute

    Chicago, Illinois 60657
    United States

    Active - Recruiting

  • Chicago Headache Center and Research Institute

    Naperville, Illinois 60563
    United States

    Active - Recruiting

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

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • New England Regional Headache Center

    Worcester, Massachusetts 01609
    United States

    Active - Recruiting

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Active - Recruiting

  • Clinvest Headlands Llc

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Rutgers University

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • OnSite Clinical Solutions

    Charlotte, North Carolina 28211
    United States

    Active - Recruiting

  • Duke Children's Health Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Duke Health Center Creekstone

    Durham, North Carolina 27703
    United States

    Active - Recruiting

  • Duke Lenox Baker Children's

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Wake Forest University Baptist Medical Center ( WFUBMC )

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • OnSite Clinical Solutions, LLC

    Charlotte 4460243, North Carolina 4482348 28211
    United States

    Active - Recruiting

  • Duke Health Center Creekstone

    Durham 4464368, North Carolina 4482348 27703
    United States

    Active - Recruiting

  • Duke Lenox Baker Children's

    Durham 4464368, North Carolina 4482348 27705
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Avera Medical Group Pediatric Specialists

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Avera Medical Group Pediatrics - Dawley Farm

    Sioux Falls, South Dakota 57110
    United States

    Active - Recruiting

  • Avera Research Institute - Sioux Falls

    Sioux Falls, South Dakota 57108
    United States

    Active - Recruiting

  • Avera Medical Group Pediatric Specialists

    Sioux Falls 5231851, South Dakota 5769223 57105
    United States

    Active - Recruiting

  • Avera Medical Group Pediatrics - Dawley Farm

    Sioux Falls 5231851, South Dakota 5769223 57110
    United States

    Active - Recruiting

  • Dell Children's Medical Center

    Austin, Texas 78723
    United States

    Active - Recruiting

  • Headlands Research-El Paso

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Granger Medical Holladay - Holladay Clinic

    Salt Lake City, Utah 84117
    United States

    Active - Recruiting

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Granger Medical Holladay - Holladay Clinic

    Salt Lake City 5780993, Utah 5549030 84117
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

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