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

Last updated: September 22, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Pain

Headaches

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

    Active - Recruiting

  • CaRe Clinic

    Red Deer, Alberta T4P 1K4
    Canada

    Site Not Available

  • Stollery Children's Hospital

    Edmonton 5946768, Alberta 5883102 T6G 2B7
    Canada

    Active - Recruiting

  • University Of Alberta Hospital

    Edmonton 5946768, Alberta 5883102 T6G 1W9
    Canada

    Active - Recruiting

  • CaRe Clinic

    Red Deer 6118158, Alberta 5883102 T4P 1K4
    Canada

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing 1816670, Beijing Municipality 2038349 100044
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400016
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing 1814906, Chongqing Municipality 1814905 400016
    China

    Active - Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • Guangzhou First People's Hospital

    Guangzhou 1809858, Guangdong 1809935 510180
    China

    Active - Recruiting

  • Jingzhou First People's Hospital

    Jingzhou, Hubei 434000
    China

    Site Not Available

  • Jingzhou First People's Hospital

    Jingzhou 1805540, Hubei 1806949 434000
    China

    Active - Recruiting

  • Wuhan Children's Hospital

    Wuhan 1791247, Hubei 1806949 430010
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410013
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691 410011
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691 410013
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Wuxi Children's Hospital

    Wuxi, Jiangsu 214023
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212000
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou 1886760, Jiangsu 1806260 215006
    China

    Active - Recruiting

  • Wuxi Children's Hospital

    Wuxi 1790923, Jiangsu 1806260 214023
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang 1784642, Jiangsu 1806260 212000
    China

    Active - Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan 1786657, Ningxia 1799355 750004
    China

    Site Not Available

  • Shanghai Children's Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200040
    China

    Site Not Available

  • The Second Affiliated Hospital of Hebei Medical University

    Shijiazhuang,
    China

    Site Not Available

  • The Second Affiliated Hospital of Hebei Medical University

    Shijiazhuang 1795270,
    China

    Active - Recruiting

  • Detska nemocnice FN Brno

    Brno 3078610, Brno-město 613 00
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove, Hradec Králové 500 05
    Czechia

    Site Not Available

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové 3074967, Hradec Králové 500 05
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Ostrava

    Ostrava, Moravskoslezský KRAJ 708 52
    Czechia

    Site Not Available

  • Fakultni nemocnice Ostrava

    Ostrava 3068799, Moravskoslezský kraj 3339573 708 52
    Czechia

    Active - Recruiting

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4 14059
    Czechia

    Site Not Available

  • Fakultni Thomayerova nemocnice

    Prague 3067696, Praha 4 14059
    Czechia

    Active - Recruiting

  • Fakultni nemocnice v Motole

    Prague 3067696, Praha 5 150 06
    Czechia

    Active - Recruiting

  • Fakultni nemocnice v Motole

    Praha, Praha 5 150 06
    Czechia

    Site Not Available

  • Terveystalo Oulu

    Oulu 643492, North Ostrobothnia 830667 90100
    Finland

    Active - Recruiting

  • Kuopion Yliopistollinen Sairaala

    Kuopio 650224, Northern Savonia 830690 70210
    Finland

    Active - Recruiting

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa 33520
    Finland

    Active - Recruiting

  • Tampereen yliopistollinen sairaala

    Tampere 634963, Pirkanmaa 830704 33520
    Finland

    Active - Recruiting

  • Terveystalo Oulu

    Oulu, Pohjois-pohjanmaa 90100
    Finland

    Site Not Available

  • Kuopion Yliopistollinen Sairaala

    Kuopio, Pohjois-savo 70210
    Finland

    Site Not Available

  • Turku University Hospital

    Turku 633679, Southwest Finland 830708 20520
    Finland

    Active - Recruiting

  • New Children's Hospital

    Helsinki, Uusimaa 00029
    Finland

    Site Not Available

  • New Children's Hospital

    Helsinki 658225, Uusimaa 830709 00029
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku, Varsinais-suomi 20520
    Finland

    Site Not Available

  • Terveystalo Tampere

    Tampere, 33100
    Finland

    Site Not Available

  • Terveystalo Tampere

    Tampere 634963, 33100
    Finland

    Active - Recruiting

  • Terveystalo Pulssi

    Turku, 20100
    Finland

    Active - Recruiting

  • Terveystalo Pulssi

    Turku 633679, 20100
    Finland

    Active - Recruiting

  • Nagykanizsai Kanizsai Dorottya Korhaz

    Nagykanizsa, Zala 8800
    Hungary

    Site Not Available

  • Nagykanizsai Kanizsai Dorottya Korhaz

    Nagykanizsa 3047679, Zala County 3042613 8800
    Hungary

    Active - Recruiting

  • Óbudai Egészségügyi Centrum

    Budapest, 1036
    Hungary

    Site Not Available

  • Óbudai Egészségügyi Centrum

    Budapest 3054643, 1036
    Hungary

    Active - Recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen 721472, 4032
    Hungary

    Active - Recruiting

  • Sir Ganga Ram Hospital

    New Delhi, Delhi 110060
    India

    Site Not Available

  • Artemis hospital

    Gurugram, Haryana 122001
    India

    Active - Recruiting

  • Fortis Memorial Research Institute

    Gurugram, Haryana 122002
    India

    Site Not Available

  • Artemis hospital

    Gurugram 1270642, Haryana 1270260 122001
    India

    Active - Recruiting

  • Fortis Memorial Research Institute

    Gurugram 1270642, Haryana 1270260 122002
    India

    Active - Recruiting

  • Mallikatta Neuro Centre

    Mangalore, Karnataka 575002
    India

    Site Not Available

  • JSS Hospital

    Mysore, Karnataka 570004
    India

    Site Not Available

  • Mallikatta Neuro Centre

    Mangalore 1263780, Karnataka 1267701 575002
    India

    Active - Recruiting

  • JSS Hospital

    Mysore 1262321, Karnataka 1267701 570004
    India

    Active - Recruiting

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

    Nashik, Maharashtra 422005
    India

    Site Not Available

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

    Nashik 1261731, Maharashtra 1264418 422005
    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

    Site Not Available

  • ASL1 Avezzano-Sulmona-L'Aquila

    L’Aquila 3175121, Abruzzo 3183560 67100
    Italy

    Active - Recruiting

  • Ospedale San Paolo Bari

    Bari 3182351, Apulia 3169778 70132
    Italy

    Active - Recruiting

  • AOU Policlinico Umberto I

    Roma, Lazio 00161
    Italy

    Active - Recruiting

  • AOU Policlinico Umberto I

    Rome 3169070, Lazio 3174976 00161
    Italy

    Active - Recruiting

  • IRCCS Istituto Neurologico Carlo Besta

    Milano, Lombardia 20133
    Italy

    Site Not Available

  • IRCCS Istituto Neurologico Carlo Besta

    Milan 3173435, Lombardy 3174618 20133
    Italy

    Active - Recruiting

  • Ospedale San Paolo Bari

    Bari, Puglia 70132
    Italy

    Site Not Available

  • Asst Spedali Civili Di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • Asst Spedali Civili Di Brescia

    Brescia 3181554, 25123
    Italy

    Active - Recruiting

  • I.C.O.T. Università La Sapienza

    Latina, 04100
    Italy

    Site Not Available

  • I.C.O.T. Università La Sapienza

    Latina 3175058, 04100
    Italy

    Active - Recruiting

  • Fondazione Istituto Neurologico C. Mondino

    Pavia, 27100
    Italy

    Site Not Available

  • Fondazione Istituto Neurologico C. Mondino

    Pavia 3171366, 27100
    Italy

    Active - Recruiting

  • IRCCS San Raffaele Roma

    Roma, 00166
    Italy

    Site Not Available

  • IRCCS San Raffaele Roma

    Roma 8957247, 00166
    Italy

    Site Not Available

  • Konan Medical Center

    Kobe, Hyogo 658-0064
    Japan

    Site Not Available

  • Yamaguchi Clinic

    Nishinomiya, Hyōgo 663-8204
    Japan

    Site Not Available

  • Konan Medical Center

    Kobe 1859171, Hyōgo 1862047 658-0064
    Japan

    Active - Recruiting

  • Yamaguchi Clinic

    Nishinomiya 1855207, Hyōgo 1862047 663-8204
    Japan

    Site Not Available

  • Tominaga Clinic

    Osaka-Shi, Osaka 556-0015
    Japan

    Site Not Available

  • Tominaga Clinic

    Osaka 1853909, Osaka 1853904 556-0015
    Japan

    Active - Recruiting

  • Tokyo Headache Clinic

    Shubuya-ku, Tokyo 151-0051
    Japan

    Site Not Available

  • Tokyo Headache Clinic

    Shibuya-ku, Tokyo 1850144 151-0051
    Japan

    Active - Recruiting

  • Nagaseki Headache Clinic

    Kai, Yamanashi 400-0124
    Japan

    Site Not Available

  • Nagaseki Headache Clinic

    Kai 11612336, Yamanashi 1848649 400-0124
    Japan

    Active - Recruiting

  • Tanaka Neurosurgery&Headache Clinic

    Kagoshima, 890-0052
    Japan

    Site Not Available

  • Tanaka Neurosurgical Clinic

    Kagoshima, 892-0844
    Japan

    Active - Recruiting

  • Tanaka Neurosurgery&Headache Clinic

    Kagoshima 1860827, 890-0052
    Japan

    Active - Recruiting

  • Tennoji Department of Neurosurgery

    Osaka, 545-0053
    Japan

    Site Not Available

  • Tennoji Department of Neurosurgery

    Osaka 1853909, 545-0053
    Japan

    Active - Recruiting

  • MIGRE Polskie Centrum Leczenia Migreny

    Wroclaw, Dolnośląskie 52-210
    Poland

    Active - Recruiting

  • MedicArt Sp. z o. o.

    Wroclaw, Dolnośląskie 53-025
    Poland

    Site Not Available

  • AthleticoMed

    Bydgoszcz, Kujawsko-pomorskie 85-752
    Poland

    Site Not Available

  • AthleticoMed

    Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-752
    Poland

    Active - Recruiting

  • Specjalistyczne Gabinety Sp. z o.o.

    Krakow 3094802, Lesser Poland Voivodeship 858786 30-539
    Poland

    Active - Recruiting

  • MIGRE Polskie Centrum Leczenia Migreny

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 52-210
    Poland

    Active - Recruiting

  • MedicArt Sp. z o. o.

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 53-025
    Poland

    Active - Recruiting

  • Centrum Medyczne Hope Clinic Sebastian Szklener

    Lublin, Lubelskie 20-701
    Poland

    Site Not Available

  • Centrum Medyczne Hope Clinic Sebastian Szklener

    Lublin 765876, Lublin Voivodeship 858785 20-701
    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

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

    Warsaw, Mazowieckie 04-501
    Poland

    Active - Recruiting

  • Neurosphera

    Warsaw, Mazowieckie 02-829
    Poland

    Site Not Available

  • Specjalistyczne Gabinety Sp. z o.o.

    Kraków, Małopolskie 30-539
    Poland

    Site Not Available

  • Detska fakultna nemocnica s poliklinikou Banska Bystrica

    Banská Bystrica, 97409
    Slovakia

    Site Not Available

  • Detska fakultna nemocnica s poliklinikou Banska Bystrica

    Banská Bystrica 3061186, 97409
    Slovakia

    Active - Recruiting

  • IN MEDIC s.r.o.

    Bardejov,
    Slovakia

    Site Not Available

  • IN MEDIC s.r.o.

    Bardejov 725168,
    Slovakia

    Active - Recruiting

  • Detsky neurolog s.r.o.

    Bratislava, 841 03
    Slovakia

    Site Not Available

  • Narodny ustav detskych chorob

    Bratislava, 833 40
    Slovakia

    Site Not Available

  • Detsky neurolog s.r.o.

    Bratislava 3060972, 841 03
    Slovakia

    Active - Recruiting

  • Narodny ustav detskych chorob

    Bratislava 3060972, 833 40
    Slovakia

    Site Not Available

  • KONZILIUM s.r.o.

    Dubnica nad Vahom,
    Slovakia

    Site Not Available

  • KONZILIUM s.r.o.

    Dubnica nad Váhom 3060346,
    Slovakia

    Active - Recruiting

  • Univerzitna nemocnica Martin

    Martin, 036 59
    Slovakia

    Site Not Available

  • Univerzitna nemocnica Martin

    Martin 3058780, 036 59
    Slovakia

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona] 08035
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760, Barcelona [barcelona] 08035
    Spain

    Active - Recruiting

  • Hospital Universitario HM Puerta del Sur

    Madrid, Madrid, Comunidad DE 28938
    Spain

    Site Not Available

  • Hospital Universitario HM Puerta del Sur

    Madrid 3117735, Madrid, Comunidad de 28938
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Active - Recruiting

  • CHUVI- Hospital Alvaro Cunqueiro

    Vigo, Pontevedra 36213
    Spain

    Site Not Available

  • CHUVI- Hospital Alvaro Cunqueiro

    Vigo 3105976, 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

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Seville 2510911, 41013
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia 2509954, 46026
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47005
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid 3106672, 47005
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Site Not Available

  • Nicklaus Children's Hospital

    Miami, Florida 33155
    United States

    Site Not Available

  • Nicklaus Children's Hospital

    Miami 4164138, Florida 4155751 33155
    United States

    Site Not Available

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Site Not Available

  • Michigan Headache & Neurological Institute

    Ann Arbor 4984247, Michigan 5001836 48104
    United States

    Active - Recruiting

  • Clinvest Headlands Llc

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Clinvest Headlands Llc

    Springfield 4409896, Missouri 4398678 65807
    United States

    Active - Recruiting

  • Rutgers University

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Rutgers University

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Active - Recruiting

  • Wake Forest University Baptist Medical Center ( WFUBMC )

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Duke Lenox Baker Children's

    Durham 4464368, North Carolina 4482348 27705
    United States

    Site Not Available

  • Wake Forest University Baptist Medical Center ( WFUBMC )

    Winston-Salem 4499612, North Carolina 4482348 27157
    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

    Site Not Available

  • 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

  • Avera Research Institute - Sioux Falls

    Sioux Falls 5231851, South Dakota 5769223 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

  • Dell Children's Medical Center

    Austin 4671654, Texas 4736286 78723
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Houston

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Granger Medical Holladay - Holladay Clinic

    Salt Lake City, Utah 84117
    United States

    Site Not Available

  • 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

  • Wasatch Clinical Research, LLC

    Salt Lake City 5780993, Utah 5549030 84107
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle 5809844, Washington 5815135 98105
    United States

    Active - Recruiting

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