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Phase 3

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

Sponsor:

Eli Lilly and Company

Code:

NCT04616326

Conditions

Chronic Migraine

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Galcanezumab

Placebo

Study Details

Brief 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.

Conditions

Chronic Migraine

Study ID

NCT04616326

Start date

Nov 25, 2020

Status verified date

Jul, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Galcanezumab

Galcanezumab administered by SQ injection.

Participants may be eligible for optional open-label extension at the end of the double-blind period.

placebo comparator: Placebo

Placebo administered by SQ injection.

Participants may be eligible for optional open-label extension at the end of the double-blind period.

Interventions

Galcanezumab

Administered SQ

Placebo

Administered SQ

Primary outcome measure

Change from Baseline in the Number of Monthly Migraine Headache Days [ Time Frame: Baseline, 3 Months ]

Central Contacts and Locations

Central contacts

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 clinical_inquiry_hub@lilly.com

Locations

Rehabilitation & Neurological Services

Recruiting

Huntsville, Alabama, United States, 35805

Contacts

256-885-9708

Principal Investigator:

Belinda Savage-Edwards, MD

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

602-933-0970

Principal Investigator:

Robert Little

Center for Neurosciences

Recruiting

Tucson, Arizona, United States, 85718

Contacts

520-320-2157

Principal Investigator:

Dinesh Talwar

Miller Children's & Women's Hospital Long Beach

Recruiting

Long Beach, California, United States, 90806

Contacts

562-490-3580

Principal Investigator:

Jasmin Dao

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

720-777-6895

Principal Investigator:

Marcy Yonker

Northwest Florida Clinical Research Group

Recruiting

Gulf Breeze, Florida, United States, 32561

Contacts

850-934-1299

Principal Investigator:

Weldon Mauney

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

904-281-5757

Principal Investigator:

Nandita Jones

Vitaly Clinical Research

Recruiting

Miami, Florida, United States, 33125

Principal Investigator:

Gabriela Perez

EMDA Clinical Research

Recruiting

Miami, Florida, United States, 33126

Principal Investigator:

Isaac Talmaciu

Allied Biomedical Research Institute

Recruiting

Miami, Florida, United States, 33155

Principal Investigator:

Michael Pfeffer

Ezy Medical Research

Recruiting

Miami, Florida, United States, 33175

Contacts

305-793-1853

Principal Investigator:

Jorge Paoli-Bruno

Wellness Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

786-483-7856

Principal Investigator:

Lucky Flores

Avanza Medical Research Center

Recruiting

Pensacola, Florida, United States, 32503

Contacts

850-477-7900

Principal Investigator:

Randall Reese

Infinity Life Research Group

Recruiting

Tamarac, Florida, United States, 33321

Principal Investigator:

Rusdany Collado Fuentes

USF Health

Recruiting

Tampa, Florida, United States, 33612

Contacts

813-396-2736

Principal Investigator:

Janice Maldonado

Medical Research Partners

Recruiting

Ammon, Idaho, United States, 83406

Contacts

208-681-9070

Principal Investigator:

Joseph Moore

Northwest Clinical Trials

Recruiting

Boise, Idaho, United States, 83704

Contacts

208-685-0600

Principal Investigator:

Brock McConnehey

St. Alexius Medical Center

Recruiting

Hoffman Estates, Illinois, United States, 60169

Principal Investigator:

Abdul Mazin

Ascension Via Christi Research

Recruiting

Wichita, Kansas, United States, 67214

Contacts

316-796-5610

Principal Investigator:

Bassem El-Nabbout

University of Kentucky Chandler Medical Center

Recruiting

Lexington, Kentucky, United States, 40536

Principal Investigator:

Sharoon Qaiser

Pharmasite Research, Inc.

Recruiting

Baltimore, Maryland, United States, 21208

Contacts

410-602-1440

Principal Investigator:

Sarah Herts

MedVadis Research Corporation

Recruiting

Waltham, Massachusetts, United States, 02451

Contacts

617-744-1310

Principal Investigator:

David DiBenedetto

Minneapolis Clinic of Neurology - Burnsville Office

Recruiting

Burnsville, Minnesota, United States, 55337

Principal Investigator:

Rajiv Aggarwal

Proven Endpoints

Recruiting

Ridgeland, Mississippi, United States, 39157

Contacts

601-790-1811

Principal Investigator:

Kristi Trimm

Saint Peter's University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator:

Amanda Barton

Dent Neurologic Institute

Recruiting

Amherst, New York, United States, 14226

Principal Investigator:

Jennifer McVige

Velocity Clinical Research at Raleigh Neurology

Recruiting

Raleigh, North Carolina, United States, 27607

Contacts

984-251-1336

Principal Investigator:

Leslie Boyce

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Principal Investigator:

marielle kabbouche Samaha

Headache Center of Hope

Recruiting

Cincinnati, Ohio, United States, 45236

Contacts

513-898-9400

Principal Investigator:

Hope O'Brien

Providence Health & Services

Recruiting

Portland, Oregon, United States, 97225

Principal Investigator:

Alison Christy

Access Clinical Trials - Nashville

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

615-320-6076

Principal Investigator:

James Fry

Medical Research Partners - Logan

Recruiting

Logan, Utah, United States, 84341

Contacts

208-681-9070

Principal Investigator:

Joseph Moore

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

206-987-2078

Principal Investigator:

Heidi Blume

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jul 23, 2025

Last verified

Jul, 2025

Keywords

pediatric
children
prevention
prophylaxis
headache
pediatric migraine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2025-07-23.