A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE
3 other identifiers
interventional
200
12 countries
102
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2024
Longer than P75 for phase_3
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2024
CompletedFirst Posted
Study publicly available on registry
September 27, 2024
CompletedStudy Start
First participant enrolled
November 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 13, 2029
July 30, 2026
July 1, 2026
3.8 years
September 24, 2024
July 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of migraine days per month
Efficacy of rimegepant relative to placebo, measured as mean change from the baseline in the number of migraine days per month
12 Weeks
Secondary Outcomes (8)
Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month
12 Weeks
Efficacy of rimegepant relative to placebo measured the mean change from baseline in the number of headache days per month
12 Weeks
Efficacy of rimegepant relative to placebo measured as the percentage of participants with at least 50% reduction from baseline in number of moderate or severe migraine days per month
12 weeks
Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score
12 Weeks
Efficacy of rimegepant relative to placebo measure as the mean change from baseline in the number of acute headache medication days per month, and acute migraine-specific medication days per month
12 Weeks
- +3 more secondary outcomes
Study Arms (2)
Rimegepant
EXPERIMENTALExperimental medicine under study
Placebo
PLACEBO COMPARATORA placebo does not have any medicine in it but looks just like the medicine being studied.
Interventions
Eligibility Criteria
You may qualify if:
- At least a 6 month history of migraine (with or without aura)
- or more headache days/month
- or more migraine days/month
- Migraine lasting 4-72 hours if untreated
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (102)
Xenoscience Inc
Phoenix, Arizona, 85004, United States
Adult & Child Neurology Medical Associates
Long Beach, California, 90806, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Chicago Headache Center and Research Institute
Chicago, Illinois, 60657, United States
Chicago Headache Center and Research Institute
Naperville, Illinois, 60563, United States
New England Regional Headache Center
Worcester, Massachusetts, 01609, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinvest Headlands Llc
Springfield, Missouri, 65807, United States
Rutgers University
New Brunswick, New Jersey, 08901, United States
OnSite Clinical Solutions
Charlotte, North Carolina, 28211, United States
Duke Health Center Creekstone
Durham, North Carolina, 27703, United States
Duke Lenox Baker Children's
Durham, North Carolina, 27705, United States
Duke Children's Health Center
Durham, North Carolina, 27710, United States
Wake Forest University Baptist Medical Center ( WFUBMC )
Winston-Salem, North Carolina, 27157, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Avera Medical Group Pediatric Specialists
Sioux Falls, South Dakota, 57105, United States
Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota, 57108, United States
Avera Medical Group Pediatrics - Dawley Farm
Sioux Falls, South Dakota, 57110, United States
Dell Children's Medical Center
Austin, Texas, 78723, United States
Headlands Research-El Paso
El Paso, Texas, 79902, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107, United States
Granger Medical Holladay - Holladay Clinic
Salt Lake City, Utah, 84117, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
University Of Alberta Hospital
Edmonton, Alberta, T6G 1W9, Canada
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7, Canada
CaRe Clinic
Red Deer, Alberta, T4P 1K4, Canada
London Health Sciences Centre - Verspeeten Family Cancer Centre
London, Ontario, N6A 5W9, Canada
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
Jingzhou First People's Hospital
Jingzhou, Hubei, 434000, China
Wuhan Children's Hospital
Wuhan, Hubei, 430010, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Wuxi Children's Hospital
Wuxi, Jiangsu, 214023, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Anhui Provincial Hospital
Hefei, 230001, China
Shanghai Children's Hospital
Shanghai, 200062, China
The Second Affiliated Hospital of Hebei Medical University
Shijiazhuang, China
Detska nemocnice FN Brno
Brno, Brno-město, 613 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, 500 05, Czechia
Fakultni nemocnice Ostrava
Ostrava, Moravian-Silesian Region, 708 52, Czechia
Fakultni Thomayerova nemocnice
Prague, Praha 4, 14059, Czechia
Fakultni Nemocnice Motol a Homolka
Prague, 150 06, Czechia
Terveystalo Oulu
Oulu, North Ostrobothnia, 90100, Finland
Kuopion Yliopistollinen Sairaala
Kuopio, Northern Savonia, 70210, Finland
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, 33520, Finland
Turku University Hospital
Turku, Southwest Finland, 20520, Finland
Clinical Research Institute Helsinki University Central Hospital Ltd
Helsinki, 00280, Finland
New Children's Hospital
Helsinki, 00290, Finland
Terveystalo Tampere
Tampere, 33100, Finland
Terveystalo Pulssi
Turku, 20100, Finland
Dr. Kenessey Albert Kórház
Balassagyarmat, Nógrád megye, 2660, Hungary
Nagykanizsai Kanizsai Dorottya Korhaz
Nagykanizsa, Zala County, 8800, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
Semmelweis Egyetem
Budapest, 1094, Hungary
Artemis hospital
Gurugram, Haryana, 122001, India
Mallikatta Neuro Centre
Mangalore, Karnataka, 575002, India
Chopda Medicare & Research Centre Pvt. Ltd; Magnum Heart Institute
Nashik, Maharashtra, 422005, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060, India
ASL1 Avezzano-Sulmona-L'Aquila
L’Aquila, Abruzzo, 67100, Italy
Ospedale San Paolo Bari
Bari, Apulia, 70132, Italy
IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, 20133, Italy
IRCCS San Raffaele Roma
Rome, ROMA, 00163, Italy
Asst Spedali Civili Di Brescia
Brescia, 25123, Italy
I.C.O.T. Università La Sapienza
Latina, 04100, Italy
Fondazione Istituto Neurologico C. Mondino
Pavia, 27100, Italy
IRCCS San Raffaele Roma
Roma, 00166, Italy
Konan Medical Center
Kobe, Hyōgo, 658-0064, Japan
Yamaguchi Clinic
Nishinomiya, Hyōgo, 663-8204, Japan
Tominaga Clinic
Osaka, Osaka, 556-0015, Japan
Tokyo Headache Clinic
Shibuya-ku, Tokyo, 151-0051, Japan
Nagaseki Headache Clinic
Kai, Yamanashi, 400-0124, Japan
Tanaka Neurosurgery&Headache Clinic
Kagoshima, 890-0052, Japan
Tennoji Department of Neurosurgery
Osaka, 545-0053, Japan
AthleticoMed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752, Poland
Specjalistyczne Gabinety Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 30-539, Poland
MIGRE Polskie Centrum Leczenia Migreny
Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
MedicArt Sp. z o. o.
Wroclaw, Lower Silesian Voivodeship, 53-025, Poland
Centrum Medyczne Hope Clinic Sebastian Szklener
Lublin, Lublin Voivodeship, 20-701, Poland
Dr Sękowska Leczenie Bólu
Warsaw, Masovian Voivodeship, 01-018, Poland
Neurosphera
Warsaw, Masovian Voivodeship, 02-829, Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship, 04-501, Poland
NZOZ Neuromed M. i M. Nastaj Sp. P.
Lublin, 20-064, Poland
Detska fakultna nemocnica s poliklinikou Banska Bystrica
Banská Bystrica, 97409, Slovakia
IN MEDIC s.r.o.
Bardejov, Slovakia
KONZILIUM s.r.o.
Dubnica nad Váhom, Slovakia
Univerzitna nemocnica Martin
Martin, 036 59, Slovakia
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035, Spain
Hospital Universitario HM Puerta del Sur
Madrid, Madrid, Comunidad de, 28938, Spain
CHUVI- Hospital Alvaro Cunqueiro
Vigo, Pontevedra, 36213, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47005, Spain
Related Publications (1)
Shin L, Mentz O, Gelfand AA, de Prado BM, Shapiro H, Oh A, Onifade OO, Saunders J, Raj N, Szperka CL. Gepants for headache prevention in children and adolescents: A multicenter chart review study. Headache. 2026 Jan;66(1):239-248. doi: 10.1111/head.15087. Epub 2025 Nov 14.
PMID: 41235617DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2024
First Posted
September 27, 2024
Study Start
November 15, 2024
Primary Completion (Estimated)
August 19, 2028
Study Completion (Estimated)
October 13, 2029
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.