ACTIVE_NOT_RECRUITING

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

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Conditions

Episodic Migrainepediatricchildrenpreventionprophylaxisheadachepediatric migraine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study

Quick Facts

Study Start:2018-03-14
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03432286

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of migraine with or without aura as defined by the IHS ICHD-3 guidelines (1.1 or 1.2 according to ICHD-3 \[2018\]), with a history of migraine headaches of at least 6 months prior to screening.
  1. * 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.
  2. * Known hypersensitivity to monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
  3. * 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.
  4. * 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).
  5. * 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.
  6. * Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.

Contacts and Locations

Principal Investigator

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)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Rehabilitation & Neurological Services
Huntsville, Alabama, 35805
United States
21st Century Neurology, a Division of Xenoscience, Inc.
Phoenix, Arizona, 85004
United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Center for Neurosciences
Tucson, Arizona, 85718
United States
Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806
United States
Wr-McCr, Llc
San Diego, California, 92108
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, 32256
United States
University of Miami Don Suffer Clinical Research Building
Miami, Florida, 33136
United States
Ezy Medical Research
Miami Lakes, Florida, 33015
United States
Clinical Neuroscience Solutions
Orlando, Florida, 32801
United States
Avanza Medical Research Center
Pensacola, Florida, 32503
United States
USF Health
Tampa, Florida, 33612
United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407
United States
Clinical Integrative Research Center of Atlanta, LLC
Atlanta, Georgia, 30328
United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
United States
Medical Research Partners
Ammon, Idaho, 83406
United States
Elite Clinical Trials
Blackfoot, Idaho, 83221
United States
Northwest Clinical Trials
Boise, Idaho, 83704
United States
Inpatient Pharmacy
Hoffman Estates, Illinois, 60169
United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
United States
Boston Clinical Trials
Boston, Massachusetts, 02131
United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451
United States
Minneapolis Clinic of Neurology - Burnsville Office
Burnsville, Minnesota, 55337
United States
Children Mercy Pediatric Clinical Research Unit
Kansas City, Missouri, 64108
United States
Dent Neurologic Institute
Amherst, New York, 14226
United States
Cohen Children's Northwell Health Physician Partners - Pediatric Neurology
New Hyde Park, New York, 11042
United States
Velocity Clinical Research at Raleigh Neurology
Raleigh, North Carolina, 27607
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Providence Health & Services
Portland, Oregon, 97225
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
Office 18
Pittsburgh, Pennsylvania, 15236
United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818
United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
United States
Pain and Headache Centers of Texas
Houston, Texas, 77054
United States
Northwest Clinical Research Center
Bellevue, Washington, 98007
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • 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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-03-14
Study Completion Date2026-11

Study Record Updates

Study Start Date2018-03-14
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • pediatric
  • children
  • prevention
  • prophylaxis
  • headache
  • pediatric migraine

Additional Relevant MeSH Terms

  • Episodic Migraine