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

Last updated: February 24, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Migraine (Pediatric)

Oral Facial Pain

Migraine And Cluster Headaches

Treatment

Galcanezumab

Placebo

Clinical Study ID

NCT04616326
16353
I5Q-MC-CGAT
2018-004622-28
  • Ages 12-17
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3according to ICHD-3 [2018]), that is, a headache occurring on 15 or more days permonth for at least the last 3 months, which has the features of migraine headache onat least 8 days per month.

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, except for antibodies to CGRP or its receptor, which are notallowed at any time prior to study entry.

  • Known hypersensitivity 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to galcanezumab, another CGRP antibody, or CGRPreceptor antibody, including those who have previously completed or withdrawn fromthis study or any other study investigating a CGRP antibody. Participant must alsonot have prior oral CGRP antagonist use within 30 days prior to baseline.

  • 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: 300
Treatment Group(s): 2
Primary Treatment: Galcanezumab
Phase: 3
Study Start date:
November 25, 2020
Estimated Completion Date:
March 31, 2026

Study Description

The 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. Enrollment in the European Union may also include participants 6 to 11 years of age.

Connect with a study center

  • Orange County Research Institute - Ontario

    Ontario, 91762
    Canada

    Active - Recruiting

  • 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 and Gentofte Hospital

    Denmark, 2730
    Denmark

    Site Not Available

  • Herlev Universitets Hospital

    Herlev, 2730
    Denmark

    Site Not Available

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille, Bouches-du-Rhône 13385
    France

    Active - Recruiting

  • Bordeaux University Hospital - Pellegrin

    Bordeaux, Gironde 33076
    France

    Active - Recruiting

  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

    Lille, Nord-Pas-de-Calais 59037
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, Paris 94010
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Estaing

    Clermont-Ferrand, Puy-de-Dôme 63100
    France

    Completed

  • Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing

    Clermont-Ferrand, Puy-de-Dôme 63100
    France

    Active - Recruiting

  • CHU d'Amiens-Picardie - Hôpital Sud

    Amiens, Somme 80054
    France

    Active - Recruiting

  • CHU Amiens - Hopital Sud

    Amiens Cedex 1, 80054
    France

    Site Not Available

  • Bordeaux University Hospital- Pellegrin

    Bordeaux, 33076
    France

    Site Not Available

  • CHRU de Lille - Service de neuropédiatrie

    Lille, 59037
    France

    Active - Recruiting

  • APHM Hôpital de la Timone

    Marseille Cedex 5, 13385
    France

    Site Not Available

  • Hôpital Armand Trousseau

    Paris, 75571
    France

    Completed

  • Praxis Dr. Astrid Gendolla

    Essen, Nordrhein-Westfalen 45133
    Germany

    Completed

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

    Essen, Nordrhein-Westfalen 45133
    Germany

    Site Not Available

  • All India Institute of Medical Sciences

    New Delhi, Delhi 110029
    India

    Active - Recruiting

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

    New Delhi, Delhi 110002
    India

    Active - Recruiting

  • Sir Ganga Ram Hospital

    New Delhi, Delhi 110060
    India

    Active - Recruiting

  • Apollo Hospitals Ahmedabad

    Ahmedabad, Gujarat 382428
    India

    Active - Recruiting

  • Artemis Hospital

    Gurgaon, Haryana 122001
    India

    Site Not Available

  • Artemis hospital

    Gurugram, Haryana 122003
    India

    Active - Recruiting

  • Mangala Hospital & Mangala Kidney Foundation

    Mangalore, Karnataka 575003
    India

    Active - Recruiting

  • P.D. Hinduja Hospital and Medical Research Centre

    Mumbai, Maharashtra 400016
    India

    Active - Recruiting

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

    Nagpur, Maharashtra 441108
    India

    Active - Recruiting

  • All India Institute of Medical Sciences - Nagpur

    Nagpur, Maharashtra 441108
    India

    Active - Recruiting

  • Central India Cardiology and Research Institute

    Nagpur, Maharashtra 440015
    India

    Active - Recruiting

  • Department of Pediatrics

    Nagpur, Maharashtra 441108
    India

    Active - Recruiting

  • Getwell Hospital and Research Institute

    Nagpur, Maharashtra 440012
    India

    Active - Recruiting

  • Lillestol Research

    Nagpur, Maharashtra 440012
    India

    Active - Recruiting

  • Medipoint Hospitals Pvt. Ltd.

    Pune, Maharashtra 411007
    India

    Active - Recruiting

  • Atmaram Child Care

    Kanpur, Uttar Pradesh 208011
    India

    Active - Recruiting

  • Apollo Gleneagles Hospitals Kolkata

    Kolkata, West Bengal 700054
    India

    Active - Recruiting

  • Universita degli Studi della Campania Luigi Vanvitelli

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • 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 Besta

    Milano, Lombardia 20133
    Italy

    Active - Recruiting

  • UOSD di Neuropsichiatria Infantile

    Napoli, Naples 80131
    Italy

    Active - Recruiting

  • Istituto Neurologico Carlo Besta

    Milano, 20133
    Italy

    Active - Recruiting

  • Neuroscience

    Roma, 165
    Italy

    Active - Recruiting

  • Ospedale Bambino Gesu

    Roma, 00165
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù

    Roma, 165
    Italy

    Site Not Available

  • 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

  • Tokyo Headache Clinic

    Shibuya-ku, Tokyo 151-0051
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Tanaka Neurosurgical Clinic

    Kagoshima, 892-0844
    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

    Mexico City, Distrito Federal 6720
    Mexico

    Active - Recruiting

  • Hospital Infantil de Mexico Federico Gomez

    Ciudad de Mexico, Federal District 6720
    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

  • Isala, locatie Zwolle

    Zwolle, Overijssel 8025 AB
    Netherlands

    Active - Recruiting

  • Ponce Medical School Foundation Inc.

    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

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona]
    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

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47010
    Spain

    Active - Recruiting

  • 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

  • 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

    Active - Recruiting

  • Orange County Research Institute - Ontario

    Ontario, California 91762
    United States

    Completed

  • Medical Center For Clinical Research

    San Diego, California 92120
    United States

    Active - Recruiting

  • Wr-McCr, Llc

    San Diego, California 92120
    United States

    Active - Recruiting

  • 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

  • Northwest Florida Clinical Research Group

    Gulf Breeze, Florida 32561
    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

  • Allied Biomedical Research Institute

    Miami, Florida 33155
    United States

    Site Not Available

  • Bio-Medical Research LLC

    Miami, Florida 33144
    United States

    Site Not Available

  • EMDA Clinical Research

    Miami, Florida 33126
    United States

    Site Not Available

  • Ezy Medical Research

    Miami, Florida 33175
    United States

    Active - Recruiting

  • University of Miami Don Suffer Clinical Research Building

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Vitaly Clinical Research

    Miami, Florida 33125
    United States

    Site Not Available

  • Wellness Clinical Research

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Wellness Clinical Research, LLC

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Private Practice - Dr. Laszlo J. Mate

    North Palm Beach, Florida 33408
    United States

    Active - Recruiting

  • Sensible Healthcare, LLC

    Ocoee, Florida 34761
    United States

    Active - Recruiting

  • Synergy Clinical Research, LLC

    Pace, Florida 32571
    United States

    Site Not Available

  • Avanza Medical Research Center

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Synergy Clinical Research, LLC

    Pensacola, Florida 32504
    United States

    Site Not Available

  • Clinical Research Center of Florida

    Pompano Beach, Florida 33060
    United States

    Site Not Available

  • Infinity Life Research Group

    Tamarac, Florida 33321
    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

  • Palm Beach Research Center

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Rare Disease Research, LLC

    Atlanta, Georgia 30329
    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

    Active - Recruiting

  • Alexian Brothers Medical Center

    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

  • Ascension Via Christi Research

    Wichita, Kansas 67214
    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

  • New England Neurological Associates, PC

    Lawrence, Massachusetts 01843
    United States

    Site Not Available

  • ActivMed Practices and Research

    Methuen, Massachusetts 01844
    United States

    Active - Recruiting

  • 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

  • Precise Research Centers

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Proven Endpoints

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • Children Mercy Pediatric Clinical Research Unit

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

  • Children's Mercy Hospital

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

  • Saint Peter's University Hospital

    New Brunswick, New Jersey 08901
    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

    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

    Active - Recruiting

  • Headache Center of Hope

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Providence Health & Services

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Completed

  • Velocity Clinical Research

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Center for Neurosciences

    Warwick, Rhode Island 02886
    United States

    Active - Recruiting

  • Velocity Clinical Research, Providence

    Warwick, Rhode Island 02886
    United States

    Active - Recruiting

  • Coastal Pediatric Research

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75235
    United States

    Completed

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75235
    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

    Active - Recruiting

  • Prime Clinical Research - Lewisville

    Lewisville, Texas 75067
    United States

    Site Not Available

  • Medical Research Partners - Logan

    Logan, Utah 84341
    United States

    Site Not Available

  • Medical Research Partners - Providence

    Logan, Utah 84341
    United States

    Site Not Available

  • Medical Research Partners - Providence

    Providence, Utah 84332
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Seattle Children's Research Institute

    Seattle, Washington 98105
    United States

    Active - Recruiting

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