A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age With Chronic Migraine - the REBUILD-2 Study
Who is this study for? Adolescent patients 12 to 17 years of age with chronic migraine
What treatments are being studied? Galcanezumab
Status: Recruiting
Location: See all (89) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:
• Have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3 according to ICHD-3 \[2018\]), that is, a headache occurring on 15 or more days per month for at least the last 3 months, which has the features of migraine headache on at least 8 days per month.
Locations
United States
Alabama
Rehabilitation & Neurological Services
RECRUITING
Huntsville
Arizona
21st Century Neurology, a Division of Xenoscience, Inc.
COMPLETED
Phoenix
Phoenix Children's Hospital
RECRUITING
Phoenix
Center for Neurosciences
COMPLETED
Tucson
Center for Neurosciences
RECRUITING
Tucson
California
Miller Children's & Women's Hospital Long Beach
RECRUITING
Long Beach
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Florida
Northwest Florida Clinical Research Group
RECRUITING
Gulf Breeze
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
RECRUITING
Jacksonville
Allied Biomedical Research Institute
RECRUITING
Miami
Bio-Medical Research LLC
NOT_YET_RECRUITING
Miami
EMDA Clinical Research
RECRUITING
Miami
Ezy Medical Research
RECRUITING
Miami
Vitaly Clinical Research
RECRUITING
Miami
Wellness Clinical Research
RECRUITING
Miami Lakes
Avanza Medical Research Center
RECRUITING
Pensacola
D&H Tamarac Research Center
NOT_YET_RECRUITING
Tamarac
Infinity Life Research Group
RECRUITING
Tamarac
USF Health
RECRUITING
Tampa
Palm Beach Research Center
NOT_YET_RECRUITING
West Palm Beach
Idaho
Medical Research Partners
RECRUITING
Ammon
Northwest Clinical Trials
RECRUITING
Boise
Illinois
St. Alexius Medical Center
RECRUITING
Hoffman Estates
Kansas
Ascension Via Christi Research
RECRUITING
Wichita
Kentucky
University of Kentucky Chandler Medical Center
RECRUITING
Lexington
Massachusetts
MedVadis Research Corporation
RECRUITING
Waltham
Maryland
Pharmasite Research, Inc.
RECRUITING
Baltimore
Minnesota
Minneapolis Clinic of Neurology - Burnsville Office
RECRUITING
Burnsville
Missouri
Children Mercy Pediatric Clinical Research Unit
COMPLETED
Kansas City
Mississippi
Precise Research Centers
NOT_YET_RECRUITING
Flowood
Proven Endpoints
RECRUITING
Ridgeland
North Carolina
Velocity Clinical Research at Raleigh Neurology
RECRUITING
Raleigh
New Jersey
Saint Peter's University Hospital
RECRUITING
New Brunswick
New York
Dent Neurologic Institute
RECRUITING
Amherst
Cohen Children's Northwell Health Physician Partners - Pediatric Neurology
COMPLETED
New Hyde Park
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Headache Center of Hope
RECRUITING
Cincinnati
Oregon
Providence Health & Services
RECRUITING
Portland
Pennsylvania
UPMC Children's Hospital of Pittsburgh
COMPLETED
Pittsburgh
South Carolina
Coastal Pediatric Research
NOT_YET_RECRUITING
Charleston
Tennessee
Access Clinical Trials - Nashville
RECRUITING
Nashville
Texas
UT Southwestern Medical Center
COMPLETED
Dallas
Prime Clinical Research - Lewisville
NOT_YET_RECRUITING
Lewisville
Utah
Medical Research Partners - Logan
RECRUITING
Logan
Washington
Northwest Clinical Research Center
COMPLETED
Bellevue
Seattle Children's Hospital
RECRUITING
Seattle
Other Locations
Denmark
Sanos Clinic - Nordjylland
RECRUITING
Aalborg
Herlev and Gentofte Hospital
RECRUITING
Copenhagen
France
CHU d'Amiens-Picardie - Hôpital Sud
RECRUITING
Amiens
Bordeaux University Hospital - Pellegrin
RECRUITING
Bordeaux
Centre Hospitalier Intercommunal de Créteil
RECRUITING
Créteil
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
RECRUITING
Lille
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
RECRUITING
Marseille
Hôpital Armand Trousseau
COMPLETED
Paris
Germany
Praxis Dr. Astrid Gendolla
COMPLETED
Essen
India
Apollo Hospitals Ahmedabad
NOT_YET_RECRUITING
Ahmedabad
Artemis hospital
NOT_YET_RECRUITING
Gurugram
Atmaram Child Care
RECRUITING
Kanpur
Mangala Hospital & Mangala Kidney Foundation
RECRUITING
Mangalore
Central India Cardiology and Research Institute
RECRUITING
Nagpur
Department of Pediatrics
RECRUITING
Nagpur
Getwell Hospital and Research Institute
RECRUITING
Nagpur
G.B. Pant Institute of Postgraduate Medical Education & Research
RECRUITING
New Delhi
Sir Ganga Ram Hospital
NOT_YET_RECRUITING
New Delhi
Medipoint Hospitals Pvt. Ltd.
RECRUITING
Pune
Italy
IRCCS Istituto Neurologico Carlo Besta
NOT_YET_RECRUITING
Milan
Neuroscience
RECRUITING
Roma
Policlinico Umberto I
RECRUITING
Rome
Japan
Tanaka Neurosurgery&Headache Clinic
RECRUITING
Kagoshima
Konan Hospital
RECRUITING
Kobe
Umenotsuji Clinic
RECRUITING
Kochi
Tatsuoka Neurology Clinic
RECRUITING
Kyoto
Yamaguchi Clinic
RECRUITING
Nishinomiya
Tominaga Hospital
RECRUITING
Osaka
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
Tokyo Headache Clinic
RECRUITING
Tokyo
Mexico
Centro de Investigacion Medica Aguascalientes (CIMA)
RECRUITING
Aguascalientes
Unidad de Investigación en Salud
RECRUITING
Chihuahua City
Hospital Civil Fray Antonio Alcalde
RECRUITING
Guadalajara
PanAmerican Clinical Research - Guadalajara
RECRUITING
Guadalajara
Hospital Infantil de Mexico Federico Gomez
NOT_YET_RECRUITING
Mexico City
Clinica De Enfermedades Cronicas y Procedimientos Especiales
RECRUITING
Morelia
Netherlands
Isala, locatie Zwolle
RECRUITING
Zwolle
Puerto Rico
Ponce Medical School Foundation Inc.
RECRUITING
Ponce
Spain
Hospital de la Santa Creu i Sant Pau
COMPLETED
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Clinico de Valencia
RECRUITING
Valencia
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
Contact Information
Primary
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
clinical_inquiry_hub@lilly.com
1-317-615-4559
Time Frame
Start Date: 2020-11-25
Estimated Completion Date: 2026-03
Participants
Target number of participants: 300
Treatments
Experimental: Galcanezumab
Galcanezumab administered by SQ injection.~Participants may be eligible for optional open-label extension at the end of the double-blind period.
Placebo_comparator: Placebo
Placebo administered by SQ injection.~Participants may be eligible for optional open-label extension at the end of the double-blind period.
Authors
Franchesca Fiorito, Todd Tyler Simmons, Christina L Szperka, Rosario Badar Retino MD, Eric Remster, Tanya R Bogle, Akiva Daum, Nandita Joshi Jones, Odette Olivieri, Monika Ummat, Peter J McAllister, Kavita Kalidas, Jennifer Dilts, Mukesh Sharma, Laurie Han-Conrad, Joshua Alta Tobin, Stephen Flitman, Desiree Ortiz-Cruz, Catalina Cleves-Bayon, David L. Fried, Mark Alan Turner, Ivan Pavkovic, Frank Berenson, Arifulla Khan, Jennifer Williams McVige, David M Bear, Ileana Fumero, Brock Aaron McConnehey, Andreas P. Schoeck, Astrid Gendolla, Catherine SARRET, Barbara Tourniaire, Laszlo J Mate, Belinda A. Savage-Edwards, Danielle Horn, Gary D. Berman, Jean-Christophe Cuvellier, Jolita Bekhof, Justine Avez-Couturier, Nanette Mol Debes, Rohit Bhatia, Vrajesh Prabhakar Udani, Licia Grazzi, Pradnya Gadgil
Sponsors
Leads: Eli Lilly and Company