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Preventive treatment for chronic migraine in adolescents using galcanezumab

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

PHASE3 · Eli Lilly and Company · NCT04616326

This study is testing if a new medication called galcanezumab can help teenagers aged 12 to 17 have fewer chronic migraine days.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment300 (estimated)
Ages12 Years to 17 Years
SexAll
SponsorEli Lilly and Company (industry)
Drugs / interventionsadalimumab, infliximab, trastuzumab, bevacizumab, galcanezumab
Locations89 sites (Huntsville, Alabama and 88 other locations)
Trial IDNCT04616326 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of galcanezumab for preventing chronic migraines in adolescents aged 12 to 17. Participants will be randomly assigned to receive either galcanezumab or a placebo during a 3-month double-blind treatment period. Following this, there will be a 9-month open-label extension where all participants will receive galcanezumab. The primary goal is to demonstrate that galcanezumab significantly reduces the number of monthly migraine headache days compared to placebo.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12 to 17 who have a diagnosis of chronic migraine occurring on 15 or more days per month.

Not a fit: Patients who have previously used therapeutic antibodies or have known hypersensitivity to galcanezumab will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of chronic migraines in adolescents, improving their quality of life.

How similar studies have performed: Other studies have shown success with similar approaches using CGRP antibodies for migraine prevention, indicating a promising avenue for treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3 according to ICHD-3 \[2018\]), that is, a headache occurring on 15 or more days per month for at least the last 3 months, which has the features of migraine headache on at least 8 days per month.

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, except for antibodies to CGRP or its receptor, which are not allowed at any time prior to study entry.
* Known hypersensitivity 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. Participant must also not have prior oral CGRP antagonist use within 30 days prior to baseline.
* 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 88 other locations

+39 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 →

Conditions: Chronic Migraine, pediatric, children, prevention, prophylaxis, headache, pediatric migraine

Last reviewed 2026-05-15 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.