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Clinical Trials in the USA / NCT03432286
Active, not recruiting Phase 3

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

NCT03432286 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2018-03-14
Last updated
2026-01-26

Condition(s) studied

Episodic Migraine

Investigational drug(s) / intervention(s)

GalcanezumabPlacebo

Galcanezumab: Administered SQ

Placebo: Administered SQ

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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.

Primary outcome measure(s)

Trial sites (73)

FacilityCityRegionStatus
Rehabilitation & Neurological Services Huntsville Alabama
21st Century Neurology, a Division of Xenoscience, Inc. Phoenix Arizona
Phoenix Children's Hospital Phoenix Arizona
Center for Neurosciences Tucson Arizona
Miller Children's & Women's Hospital Long Beach Long Beach California
Wr-McCr, Llc San Diego California
Children's Hospital Colorado Aurora Colorado
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare Jacksonville Florida
University of Miami Don Suffer Clinical Research Building Miami Florida
Ezy Medical Research Miami Lakes Florida
Clinical Neuroscience Solutions Orlando Florida
Avanza Medical Research Center Pensacola Florida
USF Health Tampa Florida
Premiere Research Institute at Palm Beach Neurology West Palm Beach Florida
Clinical Integrative Research Center of Atlanta, LLC Atlanta Georgia
Meridian Clinical Research, LLC Savannah Georgia
Medical Research Partners Ammon Idaho
Elite Clinical Trials Blackfoot Idaho
Northwest Clinical Trials Boise Idaho
Inpatient Pharmacy Hoffman Estates Illinois
University of Kentucky Chandler Medical Center Lexington Kentucky
Pharmasite Research, Inc. Baltimore Maryland
Boston Clinical Trials Boston Massachusetts
MedVadis Research Corporation Waltham Massachusetts
Minneapolis Clinic of Neurology - Burnsville Office Burnsville Minnesota
Children Mercy Pediatric Clinical Research Unit Kansas City Missouri
Dent Neurologic Institute Amherst New York
Cohen Children's Northwell Health Physician Partners - Pediatric Neurology New Hyde Park New York
Velocity Clinical Research at Raleigh Neurology Raleigh North Carolina
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Providence Health & Services Portland Oregon
UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
Office 18 Pittsburgh Pennsylvania
Velocity Clinical Research, Providence East Greenwich Rhode Island
Tribe Clinical Research, LLC Greenville South Carolina
Pain and Headache Centers of Texas Houston Texas
Northwest Clinical Research Center Bellevue Washington
Seattle Children's Hospital Seattle Washington
Sanos Clinic - Nordjylland Aalborg Denmark
Herlev and Gentofte Hospital Copenhagen Denmark

+ 33 more sites — see the full list on the official registry below.

On this site

📄 Emgality (galcanezumab) drug profile →

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03432286 on ClinicalTrials.gov ↗ ← All trials in the USA