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A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine

Active, not recruitingPhase 3NCT04616326
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

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
Interventions
Sponsor
Eli Lilly and Company
Start date
2020-11-25
Primary completion
2025-12-10
Sex
All
Age range
from 12 Years to 17 Years
Results posted
No results posted in this snapshot
Countries
Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Puerto Rico, Spain, United States
Total sites listed
88

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04616326