NCT04616326

A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The 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. Enrollment in the European Union may also include participants 6 to 11 years of age.

Conditions

• Chronic Migraine

Interventions

Type	Name	Description
DRUG	Galcanezumab	Administered SQ
DRUG	Placebo	Administered SQ

Timeline

• Start date: 2020-11-25
• Primary completion: 2025-12-10
• Completion: 2027-03-01
• First posted: 2020-11-04
• Last updated: 2026-02-27

Locations

88 sites across 11 countries: United States, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study