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A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study
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.
The study has two parts which enroll separately from each other such that participants may choose to participate in either but not both: the main study and a study addendum. * The main study includes a 3-month, randomized, double-blind treatment period in which participants receive either galcanezumab or placebo, followed by a 9-month open-label extension in which all participants receive galcanezumab. * The study addendum is a stand-alone study of galcanezumab pharmacokinetics and safety in a group of participants separate from those in the main study. The study addendum includes a 5-month evaluation period after a single injection of galcanezumab, followed by a 9-month open-label extension.
Age
6 - 17 years
Sex
ALL
Healthy Volunteers
No
Rehabilitation & Neurological Services
Huntsville, Alabama, United States
21st Century Neurology, a Division of Xenoscience, Inc.
Phoenix, Arizona, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
Miller Children's & Women's Hospital Long Beach
Long Beach, California, United States
Wr-McCr, Llc
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States
University of Miami Don Suffer Clinical Research Building
Miami, Florida, United States
Ezy Medical Research
Miami Lakes, Florida, United States
Start Date
March 14, 2018
Primary Completion Date
November 14, 2025
Completion Date
November 1, 2026
Last Updated
January 26, 2026
533
ACTUAL participants
Galcanezumab
DRUG
Placebo
DRUG
Lead Sponsor
Eli Lilly and Company
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06004388