NCT03432286

A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 533 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Episodic Migraine

Interventions

Type	Name	Description
DRUG	Galcanezumab	Administered SQ
DRUG	Placebo	Administered SQ

Timeline

• Start date: 2018-03-14
• Primary completion: 2025-11-14
• Completion: 2026-11-01
• First posted: 2018-02-14
• Last updated: 2026-01-26

Locations

73 sites across 10 countries: United States, Denmark, Germany, India, Italy, Japan, Mexico, Netherlands, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study