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

Last updated: June 4, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Headaches

Pain

Oral Facial Pain

Treatment

Rimegepant

Placebo

Clinical Study ID

NCT06616194
C4951013
BHV3000-320
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

    Site Not Available

  • University Of Alberta Hospital

    Edmonton, Alberta T6G 1W9
    Canada

    Site Not Available

  • CaRe Clinic

    Red Deer, Alberta T4P 1K4
    Canada

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove, Hradec Králové 500 05
    Czechia

    Site Not Available

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4 14059
    Czechia

    Site Not Available

  • Fakultni nemocnice v Motole

    Praha, Praha 5 150 06
    Czechia

    Site Not Available

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa 33520
    Finland

    Active - Recruiting

  • Kuopion Yliopistollinen Sairaala

    Kuopio, Pohjois-savo 70210
    Finland

    Active - Recruiting

  • New Children's Hospital

    Helsinki, Uusimaa 00029
    Finland

    Site Not Available

  • Turku University Hospital

    Turku, Varsinais-suomi 20520
    Finland

    Site Not Available

  • Terveystalo Pulssi

    Turku, 20100
    Finland

    Site Not Available

  • Nagykanizsai Kanizsai Dorottya Korhaz

    Nagykanizsa, Zala 8800
    Hungary

    Site Not Available

  • Óbudai Egészségügyi Centrum

    Budapest, 1036
    Hungary

    Site Not Available

  • Sir Ganga Ram Hospital

    New Delhi, Delhi 110060
    India

    Site Not Available

  • Artemis hospital

    Gurugram, Haryana 122001
    India

    Site Not Available

  • Fortis Memorial Research Institute

    Gurugram, Haryana 122002
    India

    Site Not Available

  • Mallikatta Neuro Centre

    Mangalore, Karnataka 575002
    India

    Site Not Available

  • JSS Hospital

    Mysore, Karnataka 570004
    India

    Site Not Available

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

    Nashik, Maharashtra 422005
    India

    Site Not Available

  • AOU Policlinico Umberto I

    Roma, Lazio 00161
    Italy

    Site Not Available

  • IRCCS Istituto Neurologico Carlo Besta

    Milano, Lombardia 20133
    Italy

    Active - Recruiting

  • Ospedale San Paolo Bari

    Bari, Puglia 70132
    Italy

    Active - Recruiting

  • I.C.O.T. Università La Sapienza

    Latina, 04100
    Italy

    Site Not Available

  • Konan Medical Center

    Kobe, Hyogo 658-0064
    Japan

    Active - Recruiting

  • Yamaguchi Clinic

    Nishinomiya, Hyōgo 663-8204
    Japan

    Site Not Available

  • Tominaga Clinic

    Osaka-Shi, Osaka 556-0015
    Japan

    Active - Recruiting

  • Tokyo Headache Clinic

    Shibuya-ku, Tokyo 151-0051
    Japan

    Active - Recruiting

  • Tokyo Headache Clinic

    Shubuya-ku, Tokyo 151-0051
    Japan

    Site Not Available

  • 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

  • MIGRE Polskie Centrum Leczenia Migreny

    Wroclaw, Dolnośląskie 52-210
    Poland

    Site Not Available

  • MedicArt Sp. z o. o.

    Wroclaw, Dolnośląskie 53-025
    Poland

    Site Not Available

  • AthleticoMed

    Bydgoszcz, Kujawsko-pomorskie 85-752
    Poland

    Site Not Available

  • Centrum Medyczne Hope Clinic Sebastian Szklener

    Lublin, Lubelskie 20-701
    Poland

    Site Not Available

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

    Warsaw, Mazowieckie 04-501
    Poland

    Site Not Available

  • Neurosphera

    Warsaw, Mazowieckie 02-829
    Poland

    Site Not Available

  • Specjalistyczne Gabinety Sp. z o.o.

    Kraków, Małopolskie 30-539
    Poland

    Active - Recruiting

  • Detska fakultna nemocnica s poliklinikou Banska Bystrica

    Banská Bystrica, 97409
    Slovakia

    Site Not Available

  • IN MEDIC s.r.o.

    Bardejov,
    Slovakia

    Active - Recruiting

  • Detsky neurolog s.r.o.

    Bratislava, 841 03
    Slovakia

    Site Not Available

  • KONZILIUM s.r.o.

    Dubnica nad Vahom,
    Slovakia

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona] 08035
    Spain

    Site Not Available

  • Hospital Universitario HM Puerta del Sur

    Madrid, Madrid, Comunidad DE 28938
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • CHUVI- Hospital Alvaro Cunqueiro

    Vigo, Pontevedra 36213
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47005
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Site Not Available

  • Nicklaus Children's Hospital

    Miami, Florida 33155
    United States

    Site Not Available

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Active - Recruiting

  • Clinvest Headlands Llc

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Rutgers University

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Wake Forest University Baptist Medical Center ( WFUBMC )

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Avera Medical Group Pediatric Specialists

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Avera Research Institute - Sioux Falls

    Sioux Falls, South Dakota 57108
    United States

    Active - Recruiting

  • Dell Children's Medical Center

    Austin, Texas 78723
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • 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

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

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