A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine (REBUILD-2)
A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine (REBUILD-2)
Brief 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: November 25, 2020
Estimated Primary Completion Date: July 30, 2025
Estimated Study Completion Date: March 30, 2026
Arms:
- Experimental: Galcanezumab
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 300 |
| Actual Study start date | 25 November 2020 |
| Estimated study completion date | 30 March 2026 |