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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Chronic Migraine

In brief

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.

Key facts

Study ID

NCT04616326

Run by

Eli Lilly and Company

People needed

312

Starts

2020-11-25

Expected to finish

2027-03-01

Last updated by the study team

2026-02-27

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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 it is running

• 21st Century Neurology, a Division of Xenoscience, Inc. — Phoenix, Arizona, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Center for Neurosciences — Tucson, Arizona, United States
• Miller Children's & Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Northwest Florida Clinical Research Group — Gulf Breeze, Florida, United States
• Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Jacksonville, Florida, United States
• Vitaly Clinical Research — Miami, Florida, United States
• EMDA Clinical Research — Miami, Florida, United States
• Bio-Medical Research LLC — Miami, Florida, United States
• Allied Biomedical Research Institute — Miami, Florida, United States
• Ezy Medical Research — Miami Lakes, Florida, United States
• Wellness Clinical Research — Miami Lakes, Florida, United States
• Avanza Medical Research Center — Pensacola, Florida, United States
• D&H Tamarac Research Center — Tamarac, Florida, United States
• Infinity Life Research Group — Tamarac, Florida, United States
• USF Health — Tampa, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Medical Research Partners — Ammon, Idaho, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• St. Alexius Medical Center — Hoffman Estates, Illinois, United States
• Ascension Via Christi Research — Wichita, Kansas, United States
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• Pharmasite Research, Inc. — Baltimore, Maryland, United States
• Rehabilitation & Neurological Services — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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