Actively Recruiting

Phase 3
Age: 12Years - 17Years
All Genders
NCT06616194

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

Led by Pfizer · Updated on 2026-05-14

200

Participants Needed

107

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least a 6 month history of migraine (with or without aura)
  • 15 or more headache days per month
  • 8 or more migraine days per month
  • Migraine lasting 4 to 72 hours if untreated
Not Eligible

You will not qualify if you...

  • Unrelenting headache
  • Current psychiatric condition uncontrolled or untreated
  • History of suicidal behavior or 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
  • Participation in another clinical trial at the same time

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 107 locations

1

Xenoscience Inc

Phoenix, Arizona, United States, 85004

Actively Recruiting

2

Adult & Child Neurology Medical Associates

Long Beach, California, United States, 90806

Actively Recruiting

3

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

4

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

Chicago, Illinois, United States, 60611

Actively Recruiting

5

Chicago Headache Center and Research Institute

Chicago, Illinois, United States, 60657

Actively Recruiting

6

Chicago Headache Center and Research Institute

Naperville, Illinois, United States, 60563

Actively Recruiting

7

New England Regional Headache Center

Worcester, Massachusetts, United States, 01609

Actively Recruiting

8

Michigan Headache & Neurological Institute

Ann Arbor, Michigan, United States, 48104

Actively Recruiting

9

Clinvest Headlands Llc

Springfield, Missouri, United States, 65807

Actively Recruiting

10

Rutgers University

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

11

OnSite Clinical Solutions

Charlotte, North Carolina, United States, 28211

Actively Recruiting

12

Duke Health Center Creekstone

Durham, North Carolina, United States, 27703

Actively Recruiting

13

Duke Lenox Baker Children's

Durham, North Carolina, United States, 27705

Actively Recruiting

14

Duke Children's Health Center

Durham, North Carolina, United States, 27710

Actively Recruiting

15

Wake Forest University Baptist Medical Center ( WFUBMC )

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

16

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

17

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

18

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

19

Avera Medical Group Pediatric Specialists

Sioux Falls, South Dakota, United States, 57105

Actively Recruiting

20

Avera Research Institute - Sioux Falls

Sioux Falls, South Dakota, United States, 57108

Actively Recruiting

21

Avera Medical Group Pediatrics - Dawley Farm

Sioux Falls, South Dakota, United States, 57110

Actively Recruiting

22

Dell Children's Medical Center

Austin, Texas, United States, 78723

Actively Recruiting

23

Headlands Research-El Paso

El Paso, Texas, United States, 79902

Actively Recruiting

24

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

25

Wasatch Clinical Research, LLC

Salt Lake City, Utah, United States, 84107

Actively Recruiting

26

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

27

University Of Alberta Hospital

Edmonton, Alberta, Canada, T6G 1W9

Actively Recruiting

28

Stollery Children's Hospital

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

29

CaRe Clinic

Red Deer, Alberta, Canada, T4P 1K4

Actively Recruiting

30

London Health Sciences Centre - Verspeeten Family Cancer Centre

London, Ontario, Canada, N6A 5W9

Actively Recruiting

31

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

32

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400016

Actively Recruiting

33

Guangzhou First People's Hospital

Guangzhou, Guangdong, China, 510180

Actively Recruiting

34

Jingzhou First People's Hospital

Jingzhou, Hubei, China, 434000

Actively Recruiting

35

Wuhan Children's Hospital

Wuhan, Hubei, China, 430010

Actively Recruiting

36

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China, 410011

Actively Recruiting

37

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China, 410013

Actively Recruiting

38

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

39

Wuxi Children's Hospital

Wuxi, Jiangsu, China, 214023

Actively Recruiting

40

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China, 212001

Actively Recruiting

41

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China, 750004

Actively Recruiting

42

Anhui Provincial Hospital

Hefei, China, 230001

Actively Recruiting

43

Shanghai Children's Hospital

Shanghai, China, 200062

Actively Recruiting

44

The Second Affiliated Hospital of Hebei Medical University

Shijiazhuang, China

Actively Recruiting

45

Detska nemocnice FN Brno

Brno, Brno-město, Czechia, 613 00

Actively Recruiting

46

Fakultni nemocnice Hradec Kralove

Hradec Králové, Hradec Králové, Czechia, 500 05

Actively Recruiting

47

Fakultni nemocnice Ostrava

Ostrava, Moravian-Silesian Region, Czechia, 708 52

Actively Recruiting

48

Fakultni Thomayerova nemocnice

Prague, Praha 4, Czechia, 14059

Actively Recruiting

49

Fakultni Nemocnice Motol a Homolka

Prague, Czechia, 150 06

Actively Recruiting

50

Terveystalo Oulu

Oulu, North Ostrobothnia, Finland, 90100

Actively Recruiting

51

Kuopion Yliopistollinen Sairaala

Kuopio, Northern Savonia, Finland, 70210

Actively Recruiting

52

Tampereen yliopistollinen sairaala

Tampere, Pirkanmaa, Finland, 33520

Actively Recruiting

53

Turku University Hospital

Turku, Southwest Finland, Finland, 20520

Actively Recruiting

54

Clinical Research Institute Helsinki University Central Hospital Ltd

Helsinki, Finland, 00280

Actively Recruiting

55

New Children's Hospital

Helsinki, Finland, 00290

Actively Recruiting

56

Terveystalo Tampere

Tampere, Finland, 33100

Actively Recruiting

57

Terveystalo Pulssi

Turku, Finland, 20100

Actively Recruiting

58

Dr. Kenessey Albert Kórház

Balassagyarmat, Nógrád megye, Hungary, 2660

Actively Recruiting

59

Nagykanizsai Kanizsai Dorottya Korhaz

Nagykanizsa, Zala County, Hungary, 8800

Actively Recruiting

60

Óbudai Egészségügyi Centrum

Budapest, Hungary, 1036

Actively Recruiting

61

Semmelweis Egyetem

Budapest, Hungary, 1083

Actively Recruiting

62

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Actively Recruiting

63

Artemis hospital

Gurugram, Haryana, India, 122001

Actively Recruiting

64

Fortis Memorial Research Institute

Gurugram, Haryana, India, 122002

Actively Recruiting

65

Mallikatta Neuro Centre

Mangalore, Karnataka, India, 575002

Actively Recruiting

66

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

Nashik, Maharashtra, India, 422005

Actively Recruiting

67

All India Institute of Medical Sciences

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

Actively Recruiting

68

Sir Ganga Ram Hospital

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

Actively Recruiting

69

ASL1 Avezzano-Sulmona-L'Aquila

L’Aquila, Abruzzo, Italy, 67100

Actively Recruiting

70

Ospedale San Paolo Bari

Bari, Apulia, Italy, 70132

Actively Recruiting

71

AOU Policlinico Umberto I

Rome, Lazio, Italy, 00161

Actively Recruiting

72

IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy, 20133

Actively Recruiting

73

IRCCS San Raffaele Roma

Rome, ROMA, Italy, 00163

Actively Recruiting

74

Asst Spedali Civili Di Brescia

Brescia, Italy, 25123

Actively Recruiting

75

I.C.O.T. Università La Sapienza

Latina, Italy, 04100

Actively Recruiting

76

Fondazione Istituto Neurologico C. Mondino

Pavia, Italy, 27100

Actively Recruiting

77

IRCCS San Raffaele Roma

Roma, Italy, 00166

Actively Recruiting

78

Konan Medical Center

Kobe, Hyōgo, Japan, 658-0064

Actively Recruiting

79

Yamaguchi Clinic

Nishinomiya, Hyōgo, Japan, 663-8204

Actively Recruiting

80

Tominaga Clinic

Osaka, Osaka, Japan, 556-0015

Actively Recruiting

81

Tokyo Headache Clinic

Shibuya-ku, Tokyo, Japan, 151-0051

Actively Recruiting

82

Nagaseki Headache Clinic

Kai, Yamanashi, Japan, 400-0124

Actively Recruiting

83

Tanaka Neurosurgery&Headache Clinic

Kagoshima, Japan, 890-0052

Actively Recruiting

84

Tennoji Department of Neurosurgery

Osaka, Japan, 545-0053

Actively Recruiting

85

AthleticoMed

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

Actively Recruiting

86

Specjalistyczne Gabinety Sp. z o.o.

Krakow, Lesser Poland Voivodeship, Poland, 30-539

Actively Recruiting

87

MIGRE Polskie Centrum Leczenia Migreny

Wroclaw, Lower Silesian Voivodeship, Poland, 52-210

Actively Recruiting

88

MedicArt Sp. z o. o.

Wroclaw, Lower Silesian Voivodeship, Poland, 53-025

Actively Recruiting

89

Centrum Medyczne Hope Clinic Sebastian Szklener

Lublin, Lublin Voivodeship, Poland, 20-701

Actively Recruiting

90

Dr Sękowska Leczenie Bólu

Warsaw, Masovian Voivodeship, Poland, 01-018

Actively Recruiting

91

Neurosphera

Warsaw, Masovian Voivodeship, Poland, 02-829

Actively Recruiting

92

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

Warsaw, Masovian Voivodeship, Poland, 04-501

Actively Recruiting

93

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

Lublin, Poland, 20-064

Actively Recruiting

94

Detska fakultna nemocnica s poliklinikou Banska Bystrica

Banská Bystrica, Slovakia, 97409

Actively Recruiting

95

IN MEDIC s.r.o.

Bardejov, Slovakia

Actively Recruiting

96

Narodny ustav detskych chorob

Bratislava, Slovakia, 833 40

Actively Recruiting

97

Detsky neurolog s.r.o.

Bratislava, Slovakia, 841 03

Actively Recruiting

98

KONZILIUM s.r.o.

Dubnica nad Váhom, Slovakia

Actively Recruiting

99

Univerzitna nemocnica Martin

Martin, Slovakia, 036 59

Actively Recruiting

100

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], Spain, 08035

Actively Recruiting

101

Hospital Universitario HM Puerta del Sur

Madrid, Madrid, Comunidad de, Spain, 28938

Actively Recruiting

102

Clinica Universidad de Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

103

CHUVI- Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain, 36213

Actively Recruiting

104

Hospital Universitario HM Sanchinarro

Madrid, Spain, 28050

Actively Recruiting

105

Hospital Universitario Virgen Del Rocio

Seville, Spain, 41013

Actively Recruiting

106

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Actively Recruiting

107

Hospital Clínico Universitario de Valladolid

Valladolid, Spain, 47005

Actively Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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