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Evaluating Galcanezumab for Preventing Migraines in Children and Teens

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

Phase 3 Interventional Eli Lilly and Company · NCT03432286

This study is testing if a new migraine medicine called galcanezumab can help prevent migraines in kids and teens aged 6 to 17.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment325 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsadalimumab, infliximab, trastuzumab, bevacizumab, galcanezumab
Locations73 sites (Huntsville, Alabama and 72 other locations)
Trial IDNCT03432286 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of galcanezumab in children and adolescents aged 6 to 17 years for the preventive treatment of episodic migraine. It consists of a 3-month randomized, double-blind treatment phase where participants receive either galcanezumab or a placebo, followed by a 9-month open-label extension where all participants will receive galcanezumab. Additionally, there is a separate study addendum focusing on the pharmacokinetics and safety of galcanezumab after a single injection, with a 5-month evaluation period and a subsequent 9-month open-label extension.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 6 to 17 years with a diagnosis of episodic migraine.

Not a fit: Patients with a history of certain migraine subtypes or those currently using therapeutic antibodies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of migraine attacks in pediatric patients.

How similar studies have performed: Previous studies have shown promising results with similar CGRP-targeting therapies in adults, indicating potential for success in pediatric populations.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have a diagnosis of migraine with or without aura as defined by the IHS ICHD-3 guidelines (1.1 or 1.2 according to ICHD-3 \[2018\]), with a history of migraine headaches of at least 6 months prior to screening.

Exclusion Criteria:

* Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.). Prior use of therapeutic antibodies is allowed if that use was more than 12 months prior to baseline.
* Known hypersensitivity to monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
* Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.
* History of IHS ICHD-3 diagnosis of new daily persistent headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine).
* History of significant head or neck injury within 6 months prior to screening; or traumatic head injury at any time that is associated with significant change in the quality or frequency of their headaches, including new onset of migraine following traumatic head injury.
* Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.

Where this trial is running

Huntsville, Alabama and 72 other locations

+23 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Episodic Migrainepediatricchildrenpreventionprophylaxisheadachepediatric migraine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.