A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine
NCT ID: NCT03432286
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
325 participants
INTERVENTIONAL
2018-03-14
2026-11-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Galcanezumab
Galcanezumab administered by SQ injection.
Participants may be eligible for optional open-label extension at the end of the double-blind period.
Galcanezumab
Administered SQ
Placebo
Placebo administered by SQ injection.
Participants may be eligible for optional open-label extension at the end of the double-blind period.
Placebo
Administered SQ
Interventions
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Galcanezumab
Administered SQ
Placebo
Administered SQ
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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.
6 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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21st Century Neurology, a Division of Xenoscience, Inc.
Phoenix, Arizona, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
Miller Children's & Women's Hospital Long Beach
Long Beach, California, United States
Wr-McCr, Llc
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States
University of Miami Don Suffer Clinical Research Building
Miami, Florida, United States
Ezy Medical Research
Miami Lakes, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
Avanza Medical Research Center
Pensacola, Florida, United States
USF Health
Tampa, Florida, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
Clinical Integrative Research Center of Atlanta, LLC
Atlanta, Georgia, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Medical Research Partners
Ammon, Idaho, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Pain and Headache Centers of Texas
Houston, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Seattle Children's Hospital
Seattle, Washington, United States
Sanos Clinic - Nordjylland
Aalborg, , Denmark
Herlev and Gentofte Hospital
Copenhagen, , Denmark
Praxis Dr. Astrid Gendolla
Essen, , Germany
Mangala Hospital & Mangala Kidney Foundation
Mangalore, , India
Getwell Hospital and Research Institute
Nagpur, , India
Central India Cardiology and Research Institute
Nagpur, , India
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, , India
G.B. Pant Institute of Postgraduate Medical Education & Research
New Delhi, , India
Ospedale Pediatrico Bambino Gesù
Roma, , Italy
Policlinico Umberto I
Roma, , Italy
Konan Hospital
Kobe, , Japan
Umenotsuji Clinic
Kochi, , Japan
Tatsuoka Neurology Clinic
Kyoto, , Japan
Rehabilitation & Neurological Services
Huntsville, Alabama, United States
Northwest Clinical Trials
Boise, Idaho, United States
Inpatient Pharmacy
Hoffman Estates, Illinois, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
MedVadis Research Corporation
Waltham, Massachusetts, United States
Minneapolis Clinic of Neurology - Burnsville Office
Burnsville, Minnesota, United States
Children Mercy Pediatric Clinical Research Unit
Kansas City, Missouri, United States
Dent Neurologic Institute
Amherst, New York, United States
Cohen Children's Northwell Health Physician Partners - Pediatric Neurology
New Hyde Park, New York, United States
Velocity Clinical Research at Raleigh Neurology
Raleigh, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Providence Health & Services
Portland, Oregon, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Office 18
Pittsburgh, Pennsylvania, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, United States
All India Institute of Medical Sciences
New Delhi, , India
Sir Ganga Ram Hospital
New Delhi, , India
Medipoint Hospitals Pvt. Ltd.
Pune, , India
IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
Yamaguchi Clinic
Nishinomiya, , Japan
Tominaga Hospital
Osaka, , Japan
Sendai Headache and Neurology Clinic
Sendai, , Japan
Tokyo Medical University Hospital
Shinjuku-ku, , Japan
Tokyo Headache Clinic
Tokyo, , Japan
Centro de Investigacion Medica Aguascalientes (CIMA)
Aguascalientes, , Mexico
Unidad de Investigación en Salud
Chihuahua City, , Mexico
Hospital Civil Fray Antonio Alcalde
Guadalajara, , Mexico
PanAmerican Clinical Research - Guadalajara
Guadalajara, , Mexico
Clinica De Enfermedades Cronicas y Procedimientos Especiales
Morelia, , Mexico
Isala, locatie Zwolle
Zwolle, , Netherlands
Dr. Samuel Sanchez PSC
Caguas, , Puerto Rico
Ponce Medical School Foundation Inc.
Ponce, , Puerto Rico
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Clinico de Valencia
Valencia, , Spain
Hospital ClÃnico Universitario de Valladolid
Valladolid, , Spain
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Facility Contacts
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Related Links
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A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine
Other Identifiers
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I5Q-MC-CGAS
Identifier Type: OTHER
Identifier Source: secondary_id
2017-004351-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16352
Identifier Type: -
Identifier Source: org_study_id
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