A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine

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

Conditions studied: Episodic Migraine

In brief

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.

Key facts

Study ID

NCT03432286

Run by

Eli Lilly and Company

People needed

533

Starts

2018-03-14

Expected to finish

2026-11-01

Last updated by the study team

2026-01-26

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.
• 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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 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
• Wr-McCr, Llc — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Jacksonville, Florida, United States
• University of Miami Don Suffer Clinical Research Building — Miami, Florida, United States
• Ezy Medical Research — Miami Lakes, Florida, United States
• Clinical Neuroscience Solutions — Orlando, Florida, United States
• Avanza Medical Research Center — Pensacola, Florida, United States
• USF Health — Tampa, Florida, United States
• Premiere Research Institute at Palm Beach Neurology — West Palm Beach, Florida, United States
• Clinical Integrative Research Center of Atlanta, LLC — Atlanta, Georgia, United States
• Meridian Clinical Research, LLC — Savannah, Georgia, United States
• Medical Research Partners — Ammon, Idaho, United States
• Elite Clinical Trials — Blackfoot, Idaho, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• Inpatient Pharmacy — Hoffman Estates, Illinois, United States
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• Pharmasite Research, Inc. — Baltimore, Maryland, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• MedVadis Research Corporation — Waltham, Massachusetts, United States
• Minneapolis Clinic of Neurology - Burnsville Office — Burnsville, Minnesota, United States
• Rehabilitation & Neurological Services — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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