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

NCT ID: NCT04616326

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-25
• Study Completion Date: 2027-03-31

Brief 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.

Detailed 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.

Conditions

Chronic Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Galcanezumab

Galcanezumab administered by SQ injection.

Participants may be eligible for optional open-label extension at the end of the double-blind period.

Group Type: EXPERIMENTAL

Galcanezumab

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SQ

Interventions

Galcanezumab

Administered SQ

Intervention Type: DRUG

Placebo

Administered SQ

Intervention Type: DRUG

Other Intervention Names

LY2951742

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Rehabilitation & Neurological Services

Huntsville, Alabama, United States

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

Children's Hospital Colorado

Aurora, Colorado, United States

Northwest Florida Clinical Research Group

Gulf Breeze, Florida, United States

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, United States

Vitaly Clinical Research

Miami, Florida, United States

EMDA Clinical Research

Miami, Florida, United States

Bio-Medical Research LLC

Miami, Florida, United States

Allied Biomedical Research Institute

Miami, Florida, United States

Ezy Medical Research

Miami Lakes, Florida, United States

Wellness Clinical Research

Miami Lakes, Florida, United States

Avanza Medical Research Center

Pensacola, Florida, United States

D&H Tamarac Research Center

Tamarac, Florida, United States

Infinity Life Research Group

Tamarac, Florida, United States

USF Health

Tampa, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Medical Research Partners

Ammon, Idaho, United States

Northwest Clinical Trials

Boise, Idaho, United States

St. Alexius Medical Center

Hoffman Estates, Illinois, United States

Ascension Via Christi Research

Wichita, Kansas, United States

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Pharmasite Research, Inc.

Baltimore, Maryland, United States

MedVadis Research Corporation

Waltham, Massachusetts, United States

Minneapolis Clinic of Neurology - Burnsville Office

Burnsville, Minnesota, United States

Precise Research Centers

Flowood, Mississippi, United States

Proven Endpoints

Ridgeland, Mississippi, United States

Children Mercy Pediatric Clinical Research Unit

Kansas City, Missouri, United States

Saint Peter's University Hospital

New Brunswick, New Jersey, 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

Headache Center of Hope

Cincinnati, Ohio, United States

Providence Health & Services

Portland, Oregon, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Coastal Pediatric Research

Charleston, South Carolina, United States

Access Clinical Trials - Nashville

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Prime Clinical Research - Lewisville

Lewisville, Texas, United States

Medical Research Partners - Logan

Logan, Utah, 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

CHU d'Amiens-Picardie - Hôpital Sud

Amiens, , France

Bordeaux University Hospital - Pellegrin

Bordeaux, , France

Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

Lille, , France

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, , France

Hôpital Armand Trousseau

Paris, , France

Praxis Dr. Astrid Gendolla

Essen, , Germany

Apollo Hospitals Ahmedabad

Ahmedabad, , India

Artemis hospital

Gurugram, , India

Atmaram Child Care

Kanpur, , India

Mangala Hospital & Mangala Kidney Foundation

Mangalore, , India

Getwell Hospital and Research Institute

Nagpur, , India

Central India Cardiology and Research Institute

Nagpur, , India

Department of Pediatrics

Nagpur, , India

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

New Delhi, , India

Sir Ganga Ram Hospital

New Delhi, , India

Medipoint Hospitals Pvt. Ltd.

Pune, , India

IRCCS Istituto Neurologico Carlo Besta

Milan, , Italy

Policlinico Umberto I

Roma, , Italy

Neuroscience

Roma, , Italy

Tanaka Neurosurgery&Headache Clinic

Kagoshima, , Japan

Konan Hospital

Kobe, , Japan

Umenotsuji Clinic

Kochi, , Japan

Tatsuoka Neurology Clinic

Kyoto, , Japan

Yamaguchi Clinic

Nishinomiya, , Japan

Tominaga Hospital

Osaka, , Japan

Tokyo Medical University Hospital

Shinjuku-ku, , Japan

Tokyo Headache Clinic

Tokyo, , Japan

Centro de Investigacion Medica Aguascalientes (CIMA)

Aguascalientes, , Mexico

Operadora Unidad de Investigación en Salud de Chihuahua S.A. de C.V.

Chihuahua City, , Mexico

Hospital Civil Fray Antonio Alcalde

Guadalajara, , Mexico

PanAmerican Clinical Research - Guadalajara

Guadalajara, , Mexico

Hospital Infantil de Mexico Federico Gomez

Mexico City, , Mexico

Clinica De Enfermedades Cronicas y Procedimientos Especiales

Morelia, , Mexico

Isala, locatie Zwolle

Zwolle, , Netherlands

Ponce Medical School Foundation Inc.

Ponce, , Puerto Rico

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Hospital Clinico de Valencia

Valencia, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Countries

United States; Denmark; France; Germany; India; Italy; Japan; Mexico; Netherlands; Puerto Rico; Spain

Related Links

https://trials.lillytrialguide.com/en-US/trial/1mozTDMc0KoyNzh7Twsl5c

A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine (REBUILD-2)

Other Identifiers

2018-004622-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

I5Q-MC-CGAT

Identifier Type: OTHER

Identifier Source: secondary_id

16353

Identifier Type: -

Identifier Source: org_study_id