Gepants for headache prevention in children and adolescents: A multicenter chart review study.
Lauren Shin, Olivia Mentz, Amy A Gelfand...
https://pubmed.ncbi.nlm.nih.gov/41235617Actively Recruiting
Phase 3
Age: 12Years - 17Years
All Genders
ID06616194
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension to Investigate Rimegepant for Migraine Prevention in Adolescents 12 to Less Than 18 Years Old
Led by Pfizer · Updated on 2026-05-22
200
Participants Needed
108
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of a medicine called rimegepant in adolescents aged 12 to less than 18 years who experience frequent migraine attacks. This study focuses on participants who have headaches for 15 or more days each month, with at least 8 of those days being migraines lasting 4 to 72 hours if untreated. The trial aims to evaluate the safety and effectiveness of rimegepant in preventing migraines in this age group. In the first phase lasting 3 months, about half of the participants will take a rimegepant tablet every other day, while the other half will receive a placebo tablet that looks identical but contains no medicine. In the second phase lasting 1 year, all participants who continue will receive rimegepant every other day to assess its long-term safety. The tablets dissolve on or under the tongue. Participants will attend up to 19 clinic visits roughly every 4 weeks, with some visits possibly occurring at home. At each visit, health checks and blood samples will be taken. Participants will also keep a daily diary to record migraine attacks. Researchers will measure the number of migraine days per month as the primary outcome and monitor safety by tracking adverse events and liver-related issues throughout the study.
CONDITIONS
Brief 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
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
- Age between 12 and 17 years
You will not qualify if you...
- Unrelenting headache
- Current uncontrolled or untreated psychiatric condition
- History of suicidal behavior or risk of self-harm
- History of alcohol abuse 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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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants take either the study medicine Rimegepant or a placebo to prevent migraines.
Weekly visits for up to 12 weeks
Follow-up
Duration - Up to 15 months
Participants are monitored for safety and long-term effects after treatment ends.
Periodic visits during follow-up
Trial Site Locations
Total: 108 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
Active, Not 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
Granger Medical Holladay - Holladay Clinic
Salt Lake City, Utah, United States, 84117
Actively Recruiting
27
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
28
University Of Alberta Hospital
Edmonton, Alberta, Canada, T6G 1W9
Actively Recruiting
29
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
30
CaRe Clinic
Red Deer, Alberta, Canada, T4P 1K4
Actively Recruiting
31
London Health Sciences Centre - Verspeeten Family Cancer Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
32
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
33
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
34
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
Actively Recruiting
35
Jingzhou First People's Hospital
Jingzhou, Hubei, China, 434000
Actively Recruiting
36
Wuhan Children's Hospital
Wuhan, Hubei, China, 430010
Actively Recruiting
37
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Actively Recruiting
38
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Actively Recruiting
39
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
40
Wuxi Children's Hospital
Wuxi, Jiangsu, China, 214023
Actively Recruiting
41
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China, 212001
Actively Recruiting
42
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China, 750004
Actively Recruiting
43
Anhui Provincial Hospital
Hefei, China, 230001
Actively Recruiting
44
Shanghai Children's Hospital
Shanghai, China, 200062
Actively Recruiting
45
The Second Affiliated Hospital of Hebei Medical University
Shijiazhuang, China
Actively Recruiting
46
Detska nemocnice FN Brno
Brno, Brno-město, Czechia, 613 00
Actively Recruiting
47
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, Czechia, 500 05
Actively Recruiting
48
Fakultni nemocnice Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 708 52
Actively Recruiting
49
Fakultni Thomayerova nemocnice
Prague, Praha 4, Czechia, 14059
Actively Recruiting
50
Fakultni Nemocnice Motol a Homolka
Prague, Czechia, 150 06
Actively Recruiting
51
Terveystalo Oulu
Oulu, North Ostrobothnia, Finland, 90100
Actively Recruiting
52
Kuopion Yliopistollinen Sairaala
Kuopio, Northern Savonia, Finland, 70210
Actively Recruiting
53
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, Finland, 33520
Actively Recruiting
54
Turku University Hospital
Turku, Southwest Finland, Finland, 20520
Actively Recruiting
55
Clinical Research Institute Helsinki University Central Hospital Ltd
Helsinki, Finland, 00280
Actively Recruiting
56
New Children's Hospital
Helsinki, Finland, 00290
Actively Recruiting
57
Terveystalo Tampere
Tampere, Finland, 33100
Actively Recruiting
58
Terveystalo Pulssi
Turku, Finland, 20100
Actively Recruiting
59
Dr. Kenessey Albert Kórház
Balassagyarmat, Nógrád megye, Hungary, 2660
Actively Recruiting
60
Nagykanizsai Kanizsai Dorottya Korhaz
Nagykanizsa, Zala County, Hungary, 8800
Actively Recruiting
61
Óbudai Egészségügyi Centrum
Budapest, Hungary, 1036
Actively Recruiting
62
Semmelweis Egyetem
Budapest, Hungary, 1083
Actively Recruiting
63
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Actively Recruiting
64
Artemis hospital
Gurugram, Haryana, India, 122001
Actively Recruiting
65
Fortis Memorial Research Institute
Gurugram, Haryana, India, 122002
Actively Recruiting
66
Mallikatta Neuro Centre
Mangalore, Karnataka, India, 575002
Actively Recruiting
67
Chopda Medicare & Research Centre Pvt. Ltd; Magnum Heart Institute
Nashik, Maharashtra, India, 422005
Actively Recruiting
68
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
Actively Recruiting
69
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India, 110060
Actively Recruiting
70
ASL1 Avezzano-Sulmona-L'Aquila
L’Aquila, Abruzzo, Italy, 67100
Actively Recruiting
71
Ospedale San Paolo Bari
Bari, Apulia, Italy, 70132
Actively Recruiting
72
AOU Policlinico Umberto I
Rome, Lazio, Italy, 00161
Actively Recruiting
73
IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy, 20133
Actively Recruiting
74
IRCCS San Raffaele Roma
Rome, ROMA, Italy, 00163
Actively Recruiting
75
Asst Spedali Civili Di Brescia
Brescia, Italy, 25123
Actively Recruiting
76
I.C.O.T. Università La Sapienza
Latina, Italy, 04100
Actively Recruiting
77
Fondazione Istituto Neurologico C. Mondino
Pavia, Italy, 27100
Actively Recruiting
78
IRCCS San Raffaele Roma
Roma, Italy, 00166
Actively Recruiting
79
Konan Medical Center
Kobe, Hyōgo, Japan, 658-0064
Actively Recruiting
80
Yamaguchi Clinic
Nishinomiya, Hyōgo, Japan, 663-8204
Actively Recruiting
81
Tominaga Clinic
Osaka, Osaka, Japan, 556-0015
Actively Recruiting
82
Tokyo Headache Clinic
Shibuya-ku, Tokyo, Japan, 151-0051
Actively Recruiting
83
Nagaseki Headache Clinic
Kai, Yamanashi, Japan, 400-0124
Actively Recruiting
84
Tanaka Neurosurgery&Headache Clinic
Kagoshima, Japan, 890-0052
Actively Recruiting
85
Tennoji Department of Neurosurgery
Osaka, Japan, 545-0053
Actively Recruiting
86
AthleticoMed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-752
Actively Recruiting
87
Specjalistyczne Gabinety Sp. z o.o.
Krakow, Lesser Poland Voivodeship, Poland, 30-539
Actively Recruiting
88
MIGRE Polskie Centrum Leczenia Migreny
Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
Actively Recruiting
89
MedicArt Sp. z o. o.
Wroclaw, Lower Silesian Voivodeship, Poland, 53-025
Actively Recruiting
90
Centrum Medyczne Hope Clinic Sebastian Szklener
Lublin, Lublin Voivodeship, Poland, 20-701
Actively Recruiting
91
Dr Sękowska Leczenie Bólu
Warsaw, Masovian Voivodeship, Poland, 01-018
Actively Recruiting
92
Neurosphera
Warsaw, Masovian Voivodeship, Poland, 02-829
Actively Recruiting
93
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship, Poland, 04-501
Actively Recruiting
94
NZOZ Neuromed M. i M. Nastaj Sp. P.
Lublin, Poland, 20-064
Actively Recruiting
95
Detska fakultna nemocnica s poliklinikou Banska Bystrica
Banská Bystrica, Slovakia, 97409
Actively Recruiting
96
IN MEDIC s.r.o.
Bardejov, Slovakia
Actively Recruiting
97
Narodny ustav detskych chorob
Bratislava, Slovakia, 833 40
Actively Recruiting
98
Detsky neurolog s.r.o.
Bratislava, Slovakia, 841 03
Actively Recruiting
99
KONZILIUM s.r.o.
Dubnica nad Váhom, Slovakia
Actively Recruiting
100
Univerzitna nemocnica Martin
Martin, Slovakia, 036 59
Actively Recruiting
101
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain, 08035
Actively Recruiting
102
Hospital Universitario HM Puerta del Sur
Madrid, Madrid, Comunidad de, Spain, 28938
Actively Recruiting
103
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
104
CHUVI- Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain, 36213
Actively Recruiting
105
Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
106
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
107
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
108
Hospital Clínico Universitario de Valladolid
Valladolid, Spain, 47005
Actively Recruiting
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Research Team
P
Pfizer CT.gov Call Center
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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