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

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.

Conditions

Chronic Migraine

Study Overview

Study Details

Study overview

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.

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

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

Condition
Chronic Migraine
Intervention / Treatment

-

Contacts and Locations

Huntsville

Rehabilitation & Neurological Services, Huntsville, Alabama, United States, 35805

Phoenix

21st Century Neurology, a Division of Xenoscience, Inc., Phoenix, Arizona, United States, 85004

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Tucson

Center for Neurosciences, Tucson, Arizona, United States, 85718

Tucson

Center for Neurosciences, Tucson, Arizona, United States, 85718

Long Beach

Miller Children's & Women's Hospital Long Beach, Long Beach, California, United States, 90806

Ontario

Orange County Research Institute, Ontario, California, United States, 91762

San Diego

Wr-McCr, Llc, San Diego, California, United States, 92120

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Jacksonville

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare, Jacksonville, Florida, United States, 32256

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.
  • * Known hypersensitivity 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. Participant must also not have prior oral CGRP antagonist use within 30 days prior to baseline.
  • * 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.

Ages Eligible for Study

12 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2026-03