Galcanezumab for Pediatric Migraine
(REBUILD-1 Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take certain therapeutic antibodies during the study.
What data supports the effectiveness of the drug Galcanezumab for treating migraines?
Is galcanezumab safe for humans?
Galcanezumab has been studied in adults for migraine prevention and is generally considered safe, with most side effects being mild to moderate. Some serious side effects were reported, such as appendicitis and Crohn's disease, but these were rare. Common side effects included injection-site pain and upper respiratory infections.14678
How is the drug Galcanezumab unique for treating pediatric migraine?
Galcanezumab is unique because it is a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP), which plays a key role in migraine development. It is administered as a once-monthly subcutaneous injection, offering a preventive approach for migraines, which is different from many other treatments that are taken more frequently or only during migraine attacks.1491011
Research Team
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Principal Investigator
Eli Lilly and Company
Eligibility Criteria
This trial is for kids and teens aged 6 to 17 with episodic migraines, as defined by IHS ICHD-3 guidelines. They must have had migraines for at least six months before screening. Those who've used certain therapeutic antibodies in the past year or are allergic to monoclonal antibodies can't join.Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Double-blind Treatment
Participants receive either galcanezumab or placebo for the prevention of episodic migraine
Open-label Extension
All participants receive galcanezumab for further evaluation of safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Galcanezumab
- Placebo
Galcanezumab is already approved in European Union, United States for the following indications:
- Prophylaxis of migraine in adults who have at least four migraine days per month
- Preventive treatment of migraine in adults
- Treatment of episodic cluster headache
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University