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

Last updated: May 22, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Oral Facial Pain

Migraine (Adult)

Migraine (Pediatric)

Treatment

Placebo

Galcanezumab

Clinical Study ID

NCT03432286
16352
I5Q-MC-CGAS
2017-004351-23
  • Ages 6-17
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of migraine with or without aura as defined by the IHS ICHD-3guidelines (1.1 or 1.2 according to ICHD-3 [2018]), with a history of migraineheadaches of at least 6 months prior to screening.

Exclusion

Exclusion Criteria:

  • Participants who are taking, or are expected to take, therapeutic antibodies duringthe course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.).Prior use of therapeutic antibodies is allowed if that use was more than 12 monthsprior to baseline.

  • Known hypersensitivity to monoclonal antibodies or other therapeutic proteins, or togalcanezumab or its excipients.

  • Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRPreceptor antibody, including those who have previously completed or withdrawn fromthis study or any other study investigating a CGRP antibody.

  • History of IHS ICHD-3 diagnosis of new daily persistent headache, cluster headacheor migraine subtypes including hemiplegic (sporadic or familial) migraine andmigraine with brainstem aura (previously basilar-type migraine).

  • History of significant head or neck injury within 6 months prior to screening; ortraumatic head injury at any time that is associated with significant change in thequality or frequency of their headaches, including new onset of migraine followingtraumatic head injury.

  • Participants with a known history of intracranial tumors or developmentalmalformations including Chiari malformations.

Study Design

Total Participants: 325
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 14, 2018
Estimated Completion Date:
November 30, 2026

Study Description

The study has two parts which enroll separately from each other such that participants may choose to participate in either but not both: the main study and a study addendum.

  • The main study includes a 3-month, randomized, double-blind treatment period in which participants receive either galcanezumab or placebo, followed by a 9-month open-label extension in which all participants receive galcanezumab.

  • The study addendum is a stand-alone study of galcanezumab pharmacokinetics and safety in a group of participants separate from those in the main study. The study addendum includes a 5-month evaluation period after a single injection of galcanezumab, followed by a 9-month open-label extension.

Connect with a study center

  • Herlev and Gentofte Hospital

    Copenhagen, Hovedstaden 2730
    Denmark

    Active - Recruiting

  • Sanos Clinic - Nordjylland

    Aalborg, Nordjylland 9362
    Denmark

    Active - Recruiting

  • Sanos Clinic Gandrup

    Gandrup, North Jutland 9362
    Denmark

    Site Not Available

  • Herlev Universitets Hospital

    Herlev, 2730
    Denmark

    Site Not Available

  • Praxis Dr. Astrid Gendolla

    Essen, Nordrhein-Westfalen 45133
    Germany

    Completed

  • Praxis Dr. med. Astrid Gendolla

    Essen, Nordrhein-Westfalen 45133
    Germany

    Completed

  • Praxis Dr. med. Astrid Gendolla Praxis für Neurologie, Psychosomatik,Nervenheilkunde, Psychotherapieund Sp -T

    Essen, Nordrhein-Westfalen 45133
    Germany

    Completed

  • Praxis Dr. med. Astrid Gendolla Praxis für Neurologie, Psychosomatik,Nervenheilkunde, Psychotherapieund Spezielle Schmerztherapie

    Essen, Nordrhein-Westfalen 45133
    Germany

    Completed

  • All India Institute of Medical Sciences

    New Delhi, Delhi 110029
    India

    Completed

  • G.B. Pant Institute of Postgraduate Medical Education & Research

    New Delhi, Delhi 110002
    India

    Completed

  • Sir Ganga Ram Hospital

    New Delhi, Delhi 110060
    India

    Completed

  • Panchshil Hospital

    Ahmedabad, Gujarat 380005
    India

    Site Not Available

  • Mangala Hospital & Mangala Kidney Foundation

    Mangalore, Karnataka 575003
    India

    Site Not Available

  • All India Institute of Medical Sciences (AIIMS) - Nagpur

    Nagpur, Maharashtra 441108
    India

    Site Not Available

  • All India Institute of Medical Sciences - Nagpur

    Nagpur, Maharashtra 441108
    India

    Active - Recruiting

  • Central India Cardiology and Research Institute

    Nagpur, Maharashtra 440015
    India

    Site Not Available

  • Getwell Hospital and Research Institute

    Nagpur, Maharashtra 440012
    India

    Completed

  • Lillestol Research

    Nagpur, Maharashtra 440012
    India

    Active - Recruiting

  • Medipoint Hospitals Pvt. Ltd.

    Pune, Maharashtra 411007
    India

    Site Not Available

  • Apollo Gleneagles Hospitals Kolkata

    Kolkata, West Bengal 700054
    India

    Site Not Available

  • Universita degli Studi della Campania Luigi Vanvitelli

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Policlinico Umberto I

    Roma, Lazio 161
    Italy

    Active - Recruiting

  • Università degli Studi di Roma La Sapienza - Policlinico Umberto I

    Rome, Lazio 00185
    Italy

    Site Not Available

  • IRCCS Istituto Neurologico Carlo

    Milano, Lombardia 20133
    Italy

    Active - Recruiting

  • IRCCS Istituto Neurologico Carlo Besta

    Milano, Lombardia 20133
    Italy

    Site Not Available

  • UOSD di Neuropsichiatria Infantile

    Napoli, Naples 80131
    Italy

    Site Not Available

  • Istituto Neurologico Carlo Besta

    Milano, 20133
    Italy

    Site Not Available

  • Ospedale Bambino Gesu

    Roma, 00165
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù

    Roma, 00165
    Italy

    Active - Recruiting

  • Università degli Studi di Roma La Sapienza - Policlinico Umberto I

    Roma, 00185
    Italy

    Active - Recruiting

  • Konan Hospital

    Kobe, Hyogo 658-0064
    Japan

    Active - Recruiting

  • Konan Medical Center

    Kobe, Hyogo 658-0064
    Japan

    Active - Recruiting

  • Yamaguchi Clinic

    Nishinomiya, Hyogo 663-8204
    Japan

    Active - Recruiting

  • Yamaguchi Clinic

    Nishinomiya-shi, Hyogo 663-8204
    Japan

    Site Not Available

  • Sendai Headache and Neurology Clinic

    Sendai, Miyagi 982-0014
    Japan

    Active - Recruiting

  • Tokyo Headache Clinic

    Shibuya-ku, Tokyo 151-0051
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Umenotsuji Clinic

    Kochi, 780-8011
    Japan

    Active - Recruiting

  • Tatsuoka Neurology Clinic

    Kyoto, 600-8811
    Japan

    Active - Recruiting

  • Tominaga Hospital

    Osaka, 556-0017
    Japan

    Active - Recruiting

  • Tokyo Headache Clinic

    Tokyo, 151-0051
    Japan

    Active - Recruiting

  • Hospital Infantil de Mexico Federico Gomez

    Ciudad de Mexico, Federal District 06720
    Mexico

    Site Not Available

  • PanAmerican Clinical Research S.A.de C.V. Guadalajara

    Guadalajara, JA 44670
    Mexico

    Active - Recruiting

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara, Jalisco 44280
    Mexico

    Active - Recruiting

  • PanAmerican Clinical Research - Guadalajara

    Guadalajara, Jalisco 44670
    Mexico

    Active - Recruiting

  • Clinica De Enfermedades Cronicas y Procedimientos Especiales

    Morelia, Michoacan 58249
    Mexico

    Active - Recruiting

  • Centro de Investigacion Medica Aguascalientes

    Aguascalientes, 20116
    Mexico

    Active - Recruiting

  • Centro de Investigacion Medica Aguascalientes (CIMA)

    Aguascalientes, 20116
    Mexico

    Active - Recruiting

  • Unidad de Investigación en Salud

    Chihuahua, 31203
    Mexico

    Active - Recruiting

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, 6720
    Mexico

    Site Not Available

  • Isala, locatie Zwolle

    Zwolle, Overijssel 8025 AB
    Netherlands

    Active - Recruiting

  • Dr. Samuel Sanchez PSC

    Caguas, 727
    Puerto Rico

    Active - Recruiting

  • Ponce Medical School Foundation Inc.

    Ponce, 00716
    Puerto Rico

    Active - Recruiting

  • Ponce School of Medicine CAIMED Center

    Ponce, 00716
    Puerto Rico

    Active - Recruiting

  • Barbara Diaz Hernandez

    San Juan, 00927
    Puerto Rico

    Active - Recruiting

  • Barbara Diaz-Hernandez MD Research, Inc.

    San Juan, 926
    Puerto Rico

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 8035
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona [Barcelona] 8041
    Spain

    Completed

  • Hospital Clinico de Valencia

    Valencia, Valenciana, Comunitat 46010
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz-NEURO

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47010
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47005
    Spain

    Active - Recruiting

  • Rehabilitation & Neurological Services

    Huntsville, Alabama 35805
    United States

    Active - Recruiting

  • 21st Century Neurology, a Division of Xenoscience, Inc.

    Phoenix, Arizona 85004
    United States

    Completed

  • 21st Century Neurology, a division of Xenoscience

    Phoenix, Arizona 85004
    United States

    Completed

  • Barrow Neurological Institute at Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Xenoscience

    Phoenix, Arizona 85004
    United States

    Completed

  • Center for Neurosciences

    Tucson, Arizona 85718
    United States

    Active - Recruiting

  • Velocity Clinical Research, Providence

    Tucson, Arizona 85718
    United States

    Active - Recruiting

  • Pine Street Pediatrics

    Exeter, California 93221
    United States

    Site Not Available

  • MemorialCare Health System - Long Beach Medical Center

    Long Beach, California 90806
    United States

    Site Not Available

  • Miller Children's & Women's Hospital Long Beach

    Long Beach, California 90806
    United States

    Active - Recruiting

  • Orange County Research Institute

    Ontario, California 91762
    United States

    Site Not Available

  • Orange County Research Institute - Ontario

    Ontario, California 91762
    United States

    Active - Recruiting

  • Medical Center For Clinical Research

    San Diego, California 92120
    United States

    Completed

  • Wr-McCr, Llc

    San Diego, California 92108
    United States

    Completed

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • New England Institute for Clinical Research

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Clinical Neuroscience Solutions Inc

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Alphab Global Research

    Jupiter, Florida 33458
    United States

    Site Not Available

  • Meridien Research

    Maitland, Florida 32751
    United States

    Site Not Available

  • Ezy Medical Research

    Miami, Florida 33175
    United States

    Active - Recruiting

  • Jackson Memorial Hospital

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Miami Don Suffer Clinical Research Building

    Miami, Florida 33136
    United States

    Site Not Available

  • Private Practice - Dr. Laszlo J. Mate

    North Palm Beach, Florida 33408
    United States

    Site Not Available

  • Sensible Healthcare, LLC

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Clinical Neuroscience Solutions

    Orlando, Florida 32801
    United States

    Completed

  • Psychiatric Inst of Florida-Clinical Neuroscience Solutions

    Orlando, Florida 32801
    United States

    Completed

  • Synergy Clinical Research, LLC

    Pace, Florida 32571
    United States

    Site Not Available

  • Avanza Medical Research Center

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Clinical Research Center of Florida

    Pompano Beach, Florida 33060
    United States

    Site Not Available

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • USF Health

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33612-4799
    United States

    Active - Recruiting

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida 33407
    United States

    Completed

  • Clinical Integrative Research Center of Atlanta, LLC

    Atlanta, Georgia 30328
    United States

    Completed

  • Rare Disease Research, LLC

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Meridian Clinical Research, LLC

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Medical Research Partners

    Ammon, Idaho 83406
    United States

    Active - Recruiting

  • Elite Clinical Trials

    Blackfoot, Idaho 83221
    United States

    Site Not Available

  • Northwest Clinical Trials

    Boise, Idaho 83704
    United States

    Active - Recruiting

  • Advanced Clinical Research LLC

    Meridian, Idaho 83642
    United States

    Active - Recruiting

  • Velocity Clinical Research, Boise

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Alexian Brothers Medical Center

    Hoffman Estates, Illinois 60169
    United States

    Active - Recruiting

  • Inpatient Pharmacy

    Hoffman Estates, Illinois 60169
    United States

    Active - Recruiting

  • St. Alexius Medical Center

    Hoffman Estates, Illinois 60169
    United States

    Active - Recruiting

  • College Park Specialty Center

    Overland Park, Kansas 66212
    United States

    Site Not Available

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • University of Kentucky College of Medicine

    Lexington, Kentucky 40504
    United States

    Active - Recruiting

  • Pharmasite Research, Inc.

    Baltimore, Maryland 21208
    United States

    Active - Recruiting

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Completed

  • New England Neurological Associates, PC

    Lawrence, Massachusetts 01843
    United States

    Site Not Available

  • ActivMed Practices and Research

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • MedVadis Research Corporation

    Waltham, Massachusetts 02451
    United States

    Active - Recruiting

  • Minneapolis Clinic of Neurology

    Burnsville, Minnesota 55337
    United States

    Active - Recruiting

  • Minneapolis Clinic of Neurology - Burnsville Office

    Burnsville, Minnesota 55337
    United States

    Active - Recruiting

  • Clinical Research Institute

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • Children Mercy Pediatric Clinical Research Unit

    Kansas City, Missouri 64108
    United States

    Completed

  • Children's Mercy Hospital

    Kansas City, Missouri 64108
    United States

    Completed

  • Clinical Research Center of Nevada

    Las Vegas, Nevada 89104
    United States

    Site Not Available

  • Bio Behavioral Health

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Dent Neurologic Institute

    Amherst, New York 14226
    United States

    Active - Recruiting

  • Northwell Health

    Great Neck, New York 11021
    United States

    Site Not Available

  • Northwell Health- Division of Pediatric Neurology

    Lake Success, New York 11042
    United States

    Site Not Available

  • Cohen Children's Northwell Health Physician Partners - Pediatric Neurology

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Rochester Clinical Research, Inc.

    Rochester, New York 14609
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Velocity Clinical Research at Raleigh

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Velocity Clinical Research at Raleigh Neurology

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Lillestol Research

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Providence Health & Services

    Portland, Oregon 97225
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Office 18

    Pittsburgh, Pennsylvania 15236
    United States

    Completed

  • Preferred Primary Care Physicians

    Pittsburgh, Pennsylvania 15236
    United States

    Completed

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Completed

  • Velocity Clinical Research

    East Greenwich, Rhode Island 02818
    United States

    Active - Recruiting

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island 02818
    United States

    Active - Recruiting

  • Center for Neurosciences

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Tribe Clinical Research, LLC

    Greenville, South Carolina 29607
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75235
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75390-9063
    United States

    Site Not Available

  • Houston Neurology Clinical & Diagnostic Consultants

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Pain and Headache Centers of Texas

    Houston, Texas 77054
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Seattle Children's Research Institute

    Seattle, Washington 98105
    United States

    Site Not Available

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