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Clinical Trials in India / NCT04616326
Active, not recruiting Phase 3

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

NCT04616326 · tracked via the Priya Life Science India tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2020-11-25
Last updated
2026-02-27

Condition(s) studied

Chronic Migraine

Investigational drug(s) / intervention(s)

GalcanezumabPlacebo

Galcanezumab: Administered SQ

Placebo: Administered SQ

Study summary

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.

Eligibility

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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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

Primary outcome measure(s)

Trial sites (88)

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
Children's Hospital Colorado Aurora Colorado
Northwest Florida Clinical Research Group Gulf Breeze Florida
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare Jacksonville Florida
Vitaly Clinical Research Miami Florida
EMDA Clinical Research Miami Florida
Bio-Medical Research LLC Miami Florida
Allied Biomedical Research Institute Miami Florida
Ezy Medical Research Miami Lakes Florida
Wellness Clinical Research Miami Lakes Florida
Avanza Medical Research Center Pensacola Florida
D&H Tamarac Research Center Tamarac Florida
Infinity Life Research Group Tamarac Florida
USF Health Tampa Florida
Palm Beach Research Center West Palm Beach Florida
Medical Research Partners Ammon Idaho
Northwest Clinical Trials Boise Idaho
St. Alexius Medical Center Hoffman Estates Illinois
Ascension Via Christi Research Wichita Kansas
University of Kentucky Chandler Medical Center Lexington Kentucky
Pharmasite Research, Inc. Baltimore Maryland
MedVadis Research Corporation Waltham Massachusetts
Minneapolis Clinic of Neurology - Burnsville Office Burnsville Minnesota
Precise Research Centers Flowood Mississippi
Proven Endpoints Ridgeland Mississippi
Children Mercy Pediatric Clinical Research Unit Kansas City Missouri
Saint Peter's University Hospital New Brunswick New Jersey
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
Headache Center of Hope Cincinnati Ohio
Providence Health & Services Portland Oregon
UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
Coastal Pediatric Research Charleston South Carolina
Access Clinical Trials - Nashville Nashville Tennessee

+ 48 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 India

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 NCT04616326 on ClinicalTrials.gov ↗ ← All trials in India