ACTIVE_NOT_RECRUITING

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

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Conditions

Chronic 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 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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age With Chronic Migraine - the REBUILD-2 Study

Quick Facts

Study Start:2020-11-25
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04616326

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:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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.
  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, except for antibodies to CGRP or its receptor, which are not allowed at any time prior to study entry.
  2. * Known hypersensitivity 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. Participant must also not have prior oral CGRP antagonist use within 30 days prior to baseline.
  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
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Northwest Florida Clinical Research Group
Gulf Breeze, Florida, 32561
United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, 32256
United States
Vitaly Clinical Research
Miami, Florida, 33125
United States
EMDA Clinical Research
Miami, Florida, 33126
United States
Bio-Medical Research LLC
Miami, Florida, 33144
United States
Allied Biomedical Research Institute
Miami, Florida, 33155
United States
Ezy Medical Research
Miami Lakes, Florida, 33015
United States
Wellness Clinical Research
Miami Lakes, Florida, 33016
United States
Avanza Medical Research Center
Pensacola, Florida, 32503
United States
D&H Tamarac Research Center
Tamarac, Florida, 33321
United States
Infinity Life Research Group
Tamarac, Florida, 33321
United States
USF Health
Tampa, Florida, 33612
United States
Palm Beach Research Center
West Palm Beach, Florida, 33409
United States
Medical Research Partners
Ammon, Idaho, 83406
United States
Northwest Clinical Trials
Boise, Idaho, 83704
United States
St. Alexius Medical Center
Hoffman Estates, Illinois, 60169
United States
Ascension Via Christi Research
Wichita, Kansas, 67214
United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451
United States
Minneapolis Clinic of Neurology - Burnsville Office
Burnsville, Minnesota, 55337
United States
Precise Research Centers
Flowood, Mississippi, 39232
United States
Proven Endpoints
Ridgeland, Mississippi, 39157
United States
Children Mercy Pediatric Clinical Research Unit
Kansas City, Missouri, 64108
United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
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
Headache Center of Hope
Cincinnati, Ohio, 45236
United States
Providence Health & Services
Portland, Oregon, 97225
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
Coastal Pediatric Research
Charleston, South Carolina, 29414
United States
Access Clinical Trials - Nashville
Nashville, Tennessee, 37203
United States
UT Southwestern Medical Center
Dallas, Texas, 75235
United States
Prime Clinical Research - Lewisville
Lewisville, Texas, 75067
United States
Medical Research Partners - Logan
Logan, Utah, 84341
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 Date2020-11-25
Study Completion Date2027-03

Study Record Updates

Study Start Date2020-11-25
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Chronic Migraine