Migraine Treatment with Galcanezumab: The REBUILD-2 Study – Phase III

Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age with Chronic Migraine – the REBUILD-2 Study

Protocol Description

The purpose of this study is to assess the effectiveness and side effects of the drug galcanezumab for adolescents, and teens who have been diagnosed with chronic migraine headaches.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling participants ages 12 through 17 who have been diagnosed with chronic migraine headaches.
Boys and Girls: Ages 12 through 17


The study is divided into five periods. In the initial 45-day screening period, participants stop taking medications. In the second period, participants track their headaches using an electronic diary for 30 to 40 days. In the third period, participants are divided into groups that will receive either galcanezumab or a placebo via monthly injections over three months. In the fourth period, all participants receive the study drug via monthly injection for nine months. The final period is a four-month follow-up stage to monitor participants’ health.
Visits: 16
Duration: About 19 months

Status: Open to Enrollment

Source(s) of Support

Eli Lilly and Company

Primary Investigator

Catalina Cleves Bayon, MD

Contact Information

For more information about the study or enrollment, please contact:
Clinical Research Coordinator Vibha Chauhan, PhD, CCRP, CCRC