A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study
Who is this study for? Patients 6 to 17 years of age with episodic migraine
Status: Recruiting
Location: See all (86) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main purpose of this study is to evaulate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. 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: 6
Maximum Age: 17
Healthy Volunteers: f
View:
• Have a diagnosis of migraine with or without aura as defined by the IHS ICHD-3 guidelines (1.1 or 1.2 according to ICHD-3 \[2018\]), with a history of migraine headaches of at least 6 months prior to screening.
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
RECRUITING
Tucson
California
Miller Children's & Women's Hospital Long Beach
RECRUITING
Long Beach
Orange County Research Institute
RECRUITING
Ontario
Wr-McCr, Llc
COMPLETED
San Diego
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Florida
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
RECRUITING
Jacksonville
Ezy Medical Research
RECRUITING
Miami
University of Miami Don Suffer Clinical Research Building
RECRUITING
Miami
Private Practice - Dr. Laszlo J. Mate
RECRUITING
North Palm Beach
Sensible Healthcare, LLC
RECRUITING
Ocoee
Clinical Neuroscience Solutions
COMPLETED
Orlando
Avanza Medical Research Center
RECRUITING
Pensacola
ForCare Clinical Research
RECRUITING
Tampa
USF Health
RECRUITING
Tampa
Premiere Research Institute at Palm Beach Neurology
COMPLETED
West Palm Beach
Georgia
Clinical Integrative Research Center of Atlanta, LLC
COMPLETED
Atlanta
Meridian Clinical Research, LLC
RECRUITING
Savannah
Idaho
Medical Research Partners
RECRUITING
Ammon
Elite Clinical Trials
RECRUITING
Blackfoot
Northwest Clinical Trials
RECRUITING
Boise
Velocity Clinical Research, Boise
RECRUITING
Meridian
Illinois
Inpatient Pharmacy
RECRUITING
Hoffman Estates
Kentucky
University of Kentucky Chandler Medical Center
RECRUITING
Lexington
Massachusetts
Boston Clinical Trials
COMPLETED
Boston
ActivMed Practices and Research
RECRUITING
Methuen
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
North Carolina
Velocity Clinical Research at Raleigh Neurology
RECRUITING
Raleigh
New York
Dent Neurologic Institute
RECRUITING
Amherst
Northwell Health
RECRUITING
Great Neck
Cohen Children's Northwell Health Physician Partners - Pediatric Neurology
RECRUITING
New Hyde Park
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Oregon
Providence Health & Services
NOT_YET_RECRUITING
Portland
Pennsylvania
Office 18
COMPLETED
Pittsburgh
UPMC Children's Hospital of Pittsburgh
COMPLETED
Pittsburgh
Rhode Island
Velocity Clinical Research, Providence
RECRUITING
East Greenwich
South Carolina
Tribe Clinical Research, LLC
RECRUITING
Greenville
Texas
UT Southwestern Medical Center
SUSPENDED
Dallas
Pain and Headache Centers of Texas
RECRUITING
Houston
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Seattle Children's Hospital
RECRUITING
Seattle
Other Locations
Denmark
Sanos Clinic - Nordjylland
RECRUITING
Aalborg
Herlev and Gentofte Hospital
RECRUITING
Copenhagen
Germany
Praxis Dr. Astrid Gendolla
COMPLETED
Essen
India
Apollo Gleneagles Hospitals Kolkata
RECRUITING
Kolkata
Mangala Hospital & Mangala Kidney Foundation
ACTIVE_NOT_RECRUITING
Mangalore
All India Institute of Medical Sciences (AIIMS) - Nagpur
ACTIVE_NOT_RECRUITING
Nagpur
Central India Cardiology and Research Institute
ACTIVE_NOT_RECRUITING
Nagpur
Getwell Hospital and Research Institute
COMPLETED
Nagpur
All India Institute of Medical Sciences
COMPLETED
New Delhi
G.B. Pant Institute of Postgraduate Medical Education & Research
COMPLETED
New Delhi
Sir Ganga Ram Hospital
COMPLETED
New Delhi
Medipoint Hospitals Pvt. Ltd.
ACTIVE_NOT_RECRUITING
Pune
Italy
IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milano
Universita degli Studi della Campania Luigi Vanvitelli
RECRUITING
Napoli
Ospedale Pediatrico Bambino Gesù
RECRUITING
Roma
Policlinico Umberto I
RECRUITING
Roma
Japan
Konan Hospital
RECRUITING
Kobe
Umenotsuji Clinic
RECRUITING
Kochi
Tatsuoka Neurology Clinic
RECRUITING
Kyoto
Yamaguchi Clinic
RECRUITING
Nishinomiya
Tominaga Hospital
RECRUITING
Osaka
Sendai Headache and Neurology Clinic
RECRUITING
Sendai
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
Hospital Civil Fray Antonio Alcalde
RECRUITING
Guadalajara
PanAmerican Clinical Research - Guadalajara
RECRUITING
Guadalajara
Hospital Infantil de Mexico Federico Gomez
RECRUITING
Mexico City
Clinica De Enfermedades Cronicas y Procedimientos Especiales
RECRUITING
Morelia
Netherlands
Isala, locatie Zwolle
RECRUITING
Zwolle
Puerto Rico
Dr. Samuel Sanchez PSC
RECRUITING
Caguas
Ponce Medical School Foundation Inc.
RECRUITING
Ponce
Barbara Diaz-Hernandez MD Research, Inc.
RECRUITING
San Juan
Spain
Hospital de la Santa Creu i Sant Pau
COMPLETED
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario La Paz-NEURO
RECRUITING
Madrid
Hospital Universitario Virgen Del Rocio
RECRUITING
Sevilla
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: 2018-03-14
Estimated Completion Date: 2026-11
Participants
Target number of participants: 325
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
Paola Verdecchia, Todd Tyler Simmons, Christina L Szperka, Rosario Badar Retino MD, Eric Remster, Tanya R Bogle, Nathan Bennett, Akiva Daum, David Sine, Nandita Joshi Jones, Ashok Patel, Dana M. Shipp, Egilius Spierings, Odette Olivieri, Arkadiy Stolyar, Peter McAllister, William Koltun, Kavita Kalidas, Jennifer Dilts, Laurie Han-Conrad, Robert Riesenberg, Joshua Tobin, Stephen Flitman, Hossam AbdelSalam, Desiree Ortiz-Cruz, Catalina Cleves-Bayon, Linda Harper, Donald Johns, David L. Fried, Mark Alan Turner, Frank Berenson, Arifulla Khan, Jennifer Williams McVige, Marielle Kabbouche-Samaha, David M Bear, Ileana Fumero, Brock Aaron McConnehey, Andreas P Schoeck, Antonio Mendes, Astrid Gendolla, Laszlo J Mate, Belinda A. Savage-Edwards, Klaus Georg Erich Werner, Paul K Winner, Gary Berman, Meenakshi Girish, Nanette Mol Debes, Sheffali Gulati, Licia Grazzi, Debashish Chowdhury
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company