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

Status: Recruiting
Location: See all (87) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
NOT_YET_RECRUITING
Chicago
Michigan
Michigan Headache & Neurological Institute
RECRUITING
Ann Arbor
Missouri
Clinvest Headlands Llc
RECRUITING
Springfield
North Carolina
OnSite Clinical Solutions
NOT_YET_RECRUITING
Charlotte
OnSite Clinical Solutions, LLC
NOT_YET_RECRUITING
Charlotte
Duke Lenox Baker Children's
NOT_YET_RECRUITING
Durham
Wake Forest University Baptist Medical Center ( WFUBMC )
RECRUITING
Winston-salem
New Jersey
Rutgers University
RECRUITING
New Brunswick
South Dakota
Avera Medical Group Pediatric Specialists
RECRUITING
Sioux Falls
Avera Medical Group Pediatrics - Dawley Farm
RECRUITING
Sioux Falls
Avera Research Institute - Sioux Falls
RECRUITING
Sioux Falls
Texas
Dell Children's Medical Center
RECRUITING
Austin
Headlands Research-El Paso
NOT_YET_RECRUITING
El Paso
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Utah
Granger Medical Holladay - Holladay Clinic
RECRUITING
Salt Lake City
Wasatch Clinical Research, LLC
RECRUITING
Salt Lake City
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Other Locations
Canada
Stollery Children's Hospital
RECRUITING
Edmonton
University Of Alberta Hospital
RECRUITING
Edmonton
CaRe Clinic
RECRUITING
Red Deer
China
Peking University People's Hospital
RECRUITING
Beijing
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Guangzhou First People's Hospital
RECRUITING
Guangzhou
Anhui Provincial Hospital
NOT_YET_RECRUITING
Hefei
Jingzhou First People's Hospital
RECRUITING
Jingzhou
Shanghai Children's Hospital
RECRUITING
Shanghai
The Second Affiliated Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Wuhan Children's Hospital
NOT_YET_RECRUITING
Wuhan
Wuxi Children's Hospital
NOT_YET_RECRUITING
Wuxi
General Hospital of Ningxia Medical University
NOT_YET_RECRUITING
Yinchuan
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
Finland
New Children's Hospital
RECRUITING
Helsinki
Kuopion Yliopistollinen Sairaala
RECRUITING
Kuopio
Terveystalo Oulu
RECRUITING
Oulu
Tampereen yliopistollinen sairaala
RECRUITING
Tampere
Terveystalo Tampere
RECRUITING
Tampere
Terveystalo Pulssi
RECRUITING
Turku
Turku University Hospital
RECRUITING
Turku
Hungary
Dr. Kenessey Albert Kórház
RECRUITING
Balassagyarmat
Óbudai Egészségügyi Centrum
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont
RECRUITING
Debrecen
Nagykanizsai Kanizsai Dorottya Korhaz
RECRUITING
Nagykanizsa
India
Artemis hospital
RECRUITING
Gurugram
Fortis Memorial Research Institute
RECRUITING
Gurugram
Mallikatta Neuro Centre
RECRUITING
Mangalore
JSS Hospital
RECRUITING
Mysore
Chopda Medicare & Research Centre Pvt. Ltd; Magnum Heart Institute
RECRUITING
Nashik
Sir Ganga Ram Hospital
RECRUITING
New Delhi
Italy
Ospedale San Paolo Bari
RECRUITING
Bari
Asst Spedali Civili Di Brescia
RECRUITING
Brescia
ASL1 Avezzano-Sulmona-L'Aquila
RECRUITING
L’aquila
I.C.O.T. Università La Sapienza
RECRUITING
Latina
IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
Fondazione Istituto Neurologico C. Mondino
RECRUITING
Pavia
IRCCS San Raffaele Roma
NOT_YET_RECRUITING
Roma
AOU Policlinico Umberto I
RECRUITING
Rome
Japan
Tanaka Neurosurgery&Headache Clinic
RECRUITING
Kagoshima
Nagaseki Headache Clinic
RECRUITING
Kai
Konan Medical Center
RECRUITING
Kobe
Yamaguchi Clinic
NOT_YET_RECRUITING
Nishinomiya
Tennoji Department of Neurosurgery
RECRUITING
Osaka
Tominaga Clinic
RECRUITING
Osaka
Tokyo Headache Clinic
RECRUITING
Shibuya-ku
Poland
AthleticoMed
RECRUITING
Bydgoszcz
Specjalistyczne Gabinety Sp. z o.o.
RECRUITING
Krakow
Centrum Medyczne Hope Clinic Sebastian Szklener
RECRUITING
Lublin
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
RECRUITING
Warsaw
Neurosphera
RECRUITING
Warsaw
MedicArt Sp. z o. o.
RECRUITING
Wroclaw
MIGRE Polskie Centrum Leczenia Migreny
RECRUITING
Wroclaw
Slovakia
Detska fakultna nemocnica s poliklinikou Banska Bystrica
RECRUITING
Banská Bystrica
IN MEDIC s.r.o.
RECRUITING
Bardejov
Detsky neurolog s.r.o.
RECRUITING
Bratislava
Narodny ustav detskych chorob
NOT_YET_RECRUITING
Bratislava
KONZILIUM s.r.o.
RECRUITING
Dubnica Nad Váhom
Univerzitna nemocnica Martin
NOT_YET_RECRUITING
Martin
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario HM Puerta del Sur
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Clinica Universidad de Navarra
RECRUITING
Pamplona
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
CHUVI- Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2024-11-15
Estimated Completion Date: 2027-12-02
Participants
Target number of participants: 200
Treatments
Experimental: Rimegepant
Experimental medicine under study
Placebo_comparator: Placebo
A placebo does not have any medicine in it but looks just like the medicine being studied.
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov