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

NCT04616326 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 163532018-004622-28I5Q-MC-CGAT
• Study Type: interventional
• Target: 312
• Locations: 11 countries
• Sites: 88

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.

Conditions

Chronic Migraine

Keywords

pediatric; children; prevention; prophylaxis; headache; pediatric migraine

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Number of Monthly Migraine Headache Days

  Change from Baseline in the Number of Monthly Migraine Headache Days

  Baseline, 3 Months

Secondary Outcomes (15)

• Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days

  3 Months

• Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting

  Baseline, 3 Months

• Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia

  Baseline, 3 Months

• Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms

  Baseline, 3 Months

• Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken

  Baseline, 3 Months

Study Arms (2)

Galcanezumab

EXPERIMENTAL

Galcanezumab administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.

Drug: Galcanezumab

Placebo

PLACEBO COMPARATOR

Placebo administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.

Drug: Placebo

Interventions

Galcanezumab DRUG

Administered SQ

Also known as: LY2951742

Galcanezumab

Placebo DRUG

Administered SQ

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (88)

Rehabilitation & Neurological Services

Huntsville, Alabama, 35805, United States

Location

21st Century Neurology, a Division of Xenoscience, Inc.

Phoenix, Arizona, 85004, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

Miller Children's & Women's Hospital Long Beach

Long Beach, California, 90806, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Northwest Florida Clinical Research Group

Gulf Breeze, Florida, 32561, United States

Location

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, 32256, United States

Location

Vitaly Clinical Research

Miami, Florida, 33125, United States

Location

EMDA Clinical Research

Miami, Florida, 33126, United States

Location

Bio-Medical Research LLC

Miami, Florida, 33144, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155, United States

Location

Ezy Medical Research

Miami Lakes, Florida, 33015, United States

Location

Wellness Clinical Research

Miami Lakes, Florida, 33016, United States

Location

Avanza Medical Research Center

Pensacola, Florida, 32503, United States

Location

D&H Tamarac Research Center

Tamarac, Florida, 33321, United States

Location

Infinity Life Research Group

Tamarac, Florida, 33321, United States

Location

USF Health

Tampa, Florida, 33612, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Medical Research Partners

Ammon, Idaho, 83406, United States

Location

Northwest Clinical Trials

Boise, Idaho, 83704, United States

Location

St. Alexius Medical Center

Hoffman Estates, Illinois, 60169, United States

Location

Ascension Via Christi Research

Wichita, Kansas, 67214, United States

Location

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

Pharmasite Research, Inc.

Baltimore, Maryland, 21208, United States

Location

MedVadis Research Corporation

Waltham, Massachusetts, 02451, United States

Location

Minneapolis Clinic of Neurology - Burnsville Office

Burnsville, Minnesota, 55337, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

Proven Endpoints

Ridgeland, Mississippi, 39157, United States

Location

Children Mercy Pediatric Clinical Research Unit

Kansas City, Missouri, 64108, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Cohen Children's Northwell Health Physician Partners - Pediatric Neurology

New Hyde Park, New York, 11042, United States

Location

Velocity Clinical Research at Raleigh Neurology

Raleigh, North Carolina, 27607, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Headache Center of Hope

Cincinnati, Ohio, 45236, United States

Location

Providence Health & Services

Portland, Oregon, 97225, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Coastal Pediatric Research

Charleston, South Carolina, 29414, United States

Location

Access Clinical Trials - Nashville

Nashville, Tennessee, 37203, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Prime Clinical Research - Lewisville

Lewisville, Texas, 75067, United States

Location

Medical Research Partners - Logan

Logan, Utah, 84341, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Sanos Clinic - Nordjylland

Aalborg, 9362, Denmark

Location

Herlev and Gentofte Hospital

Copenhagen, 2730, Denmark

Location

CHU d'Amiens-Picardie - Hôpital Sud

Amiens, 80054, France

Location

Bordeaux University Hospital - Pellegrin

Bordeaux, 33076, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

Location

Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

Lille, 59037, France

Location

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, 13385, France

Location

Hôpital Armand Trousseau

Paris, 75571, France

Location

Praxis Dr. Astrid Gendolla

Essen, 45133, Germany

Location

Apollo Hospitals Ahmedabad

Ahmedabad, 382428, India

Location

Artemis hospital

Gurugram, 122003, India

Location

Atmaram Child Care

Kanpur, 208011, India

Location

Mangala Hospital & Mangala Kidney Foundation

Mangalore, 575003, India

Location

Getwell Hospital and Research Institute

Nagpur, 440012, India

Location

Central India Cardiology and Research Institute

Nagpur, 440015, India

Location

Department of Pediatrics

Nagpur, 441108, India

Location

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

New Delhi, 110002, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

Medipoint Hospitals Pvt. Ltd.

Pune, 411007, India

Location

IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

Policlinico Umberto I

Roma, 161, Italy

Location

Neuroscience

Roma, 165, Italy

Location

Tanaka Neurosurgery&Headache Clinic

Kagoshima, 892-0844, Japan

Location

Konan Hospital

Kobe, 658-0064, Japan

Location

Umenotsuji Clinic

Kochi, 780-8011, Japan

Location

Tatsuoka Neurology Clinic

Kyoto, 600-8811, Japan

Location

Yamaguchi Clinic

Nishinomiya, 663-8204, Japan

Location

Tominaga Hospital

Osaka, 556-0017, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, 160-0023, Japan

Location

Tokyo Headache Clinic

Tokyo, 151-0051, Japan

Location

Centro de Investigacion Medica Aguascalientes (CIMA)

Aguascalientes, 20116, Mexico

Location

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

Chihuahua City, 31203, Mexico

Location

Hospital Civil Fray Antonio Alcalde

Guadalajara, 44280, Mexico

Location

PanAmerican Clinical Research - Guadalajara

Guadalajara, 44670, Mexico

Location

Hospital Infantil de Mexico Federico Gomez

Mexico City, 6720, Mexico

Location

Clinica De Enfermedades Cronicas y Procedimientos Especiales

Morelia, 58249, Mexico

Location

Isala, locatie Zwolle

Zwolle, 8025 AB, Netherlands

Location

Ponce Medical School Foundation Inc.

Ponce, 00716, Puerto Rico

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 8041, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Clinico de Valencia

Valencia, 46010, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47005, Spain

Location

Related Links

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

MeSH Terms

Conditions

Headache

Interventions

galcanezumab

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 4, 2020
• Study Start: November 25, 2020
• Primary Completion: December 10, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

IT (3); DK (2); ES (5); PR (1); DE (1); US (45); IN (10); FR (6); ME (6); NL (1); JP (8)