A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine (REBUILD-1)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Episodic Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Galcanezumab

Detailed Description

The study has two parts which enroll separately from each other such that participants may choose to participate in either but not both: the main study and a study addendum.

• The main 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.
• The study addendum is a stand-alone study of galcanezumab pharmacokinetics and safety in a group of participants separate from those in the main study. The study addendum includes a 5-month evaluation period after a single injection of galcanezumab, followed by a 9-month open-label extension.

• Study Type: Interventional
• Enrollment (Actual): 533
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9362
    • Sanos Clinic - Nordjylland
  • Copenhagen, Denmark, 2730
    • Herlev and Gentofte Hospital
• Germany
  • Essen, Germany, 45133
    • Praxis Dr. Astrid Gendolla
• India
  • Mangalore, India, 575003
    • Mangala Hospital & Mangala Kidney Foundation
  • Nagpur, India, 440015
    • Central India Cardiology and Research Institute
  • Nagpur, India, 441108
    • All India Institute of Medical Sciences (AIIMS) - Nagpur
  • Nagpur, India, 440012
    • Getwell Hospital and Research Institute
  • New Delhi, India, 110029
    • All India Institute of Medical Sciences
  • New Delhi, India, 110060
    • Sir Ganga Ram Hospital
  • New Delhi, India, 110002
    • G.B. Pant Institute of Postgraduate Medical Education & Research
  • Pune, India, 411007
    • Medipoint Hospitals Pvt. Ltd.
• Italy
  • Milan, Italy, 20133
    • IRCCS Istituto Neurologico Carlo Besta
  • Roma, Italy, 00165
    • Ospedale Pediatrico Bambino Gesu
  • Roma, Italy, 161
    • Policlinico Umberto I
• Japan
  • Kobe, Japan, 658-0064
    • Konan Hospital
  • Kochi, Japan, 780-8011
    • Umenotsuji Clinic
  • Kyoto, Japan, 600-8811
    • Tatsuoka Neurology Clinic
  • Nishinomiya, Japan, 663-8204
    • Yamaguchi Clinic
  • Osaka, Japan, 556-0017
    • Tominaga Hospital
  • Sendai, Japan, 982-0014
    • Sendai Headache and Neurology Clinic
  • Shinjuku-ku, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tokyo, Japan, 151-0051
    • Tokyo Headache Clinic
• Mexico
  • Aguascalientes, Mexico, 20116
    • Centro de Investigacion Medica Aguascalientes (CIMA)
  • Chihuahua City, Mexico, 31203
    • Operadora Unidad de Investigación en Salud de Chihuahua S.A. de C.V.
  • Guadalajara, Mexico, 44280
    • Hospital Civil Fray Antonio Alcalde
  • Guadalajara, Mexico, 44670
    • PanAmerican Clinical Research - Guadalajara
  • Morelia, Mexico, 58249
    • Clinica De Enfermedades Cronicas y Procedimientos Especiales
• Netherlands
  • Zwolle, Netherlands, 8025 AB
    • Isala, locatie Zwolle
• Puerto Rico
  • Caguas, Puerto Rico, 727
    • Dr. Samuel Sanchez PSC
  • Ponce, Puerto Rico, 00716
    • Ponce Medical School Foundation Inc.
• Spain
  • Barcelona, Spain, 8035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 8041
    • Hospital de la Santa Creu i Sant Pau
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46010
    • Hospital Clinico de Valencia
  • Valladolid, Spain, 47005
    • Hospital Clinico Universitario de Valladolid
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Rehabilitation & Neurological Services
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
    • Phoenix, Arizona, United States, 85004
      • 21st Century Neurology, a Division of Xenoscience, Inc.
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences
  • California
    • Long Beach, California, United States, 90806
      • Miller Children's & Women's Hospital Long Beach
    • San Diego, California, United States, 92108
      • Wr-McCr, Llc
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
    • Miami, Florida, United States, 33136
      • University of Miami Don Suffer Clinical Research Building
    • Miami Lakes, Florida, United States, 33015
      • Ezy Medical Research
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions
    • Pensacola, Florida, United States, 32503
      • Avanza Medical Research Center
    • Tampa, Florida, United States, 33612
      • USF Health
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute at Palm Beach Neurology
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Clinical Integrative Research Center of Atlanta, LLC
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research, LLC
  • Idaho
    • Ammon, Idaho, United States, 83406
      • Medical Research Partners
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Inpatient Pharmacy
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc.
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Waltham, Massachusetts, United States, 02451
      • MedVadis Research Corporation
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Minneapolis Clinic of Neurology - Burnsville Office
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children Mercy Pediatric Clinical Research Unit
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute
    • New Hyde Park, New York, United States, 11042
      • Cohen Children's Northwell Health Physician Partners - Pediatric Neurology
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Velocity Clinical Research at Raleigh Neurology
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Health & Services
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh
    • Pittsburgh, Pennsylvania, United States, 15236
      • Office 18
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research, Providence
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research, LLC
  • Texas
    • Houston, Texas, United States, 77054
      • Pain and Headache Centers of Texas
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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.
• Known hypersensitivity to 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Galcanezumab; Galcanezumab administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.	Drug: Galcanezumab; Administered SQ; Other Names: LY2951742
Placebo Comparator: Placebo; Placebo administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.	Drug: Placebo; Administered SQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score	Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the C-SSRS Score	Baseline through 3 Months
Percentage of Participants with Reduction from Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days	Percentage of participants with reduction from baseline ≥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	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	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	Change from baseline in the number of monthly migraine headaches with prodromal symptoms	Baseline, 3 Months
Change from Baseline in the Number of Migraine Headache Days on which Acute Headache Medication is Taken	Change from baseline in the number of migraine headache days on which acute headache medication is taken	Baseline, 3 Months
Patient Global Impression-Improvement (PGI-I) Rating	PGI-I rating	Month 1 to Month 3
Change from Baseline in the Severity of Remaining Migraine Headaches per Month	Change from baseline in the severity of remaining migraine headaches per month	Baseline, 3 Months
Change from Baseline in the Number of Monthly Headache Days	Change from baseline in the number of monthly headache days	Baseline, 3 Months
Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score	Change from Baseline on the PedsQL total score	Baseline, 3 Months
Change from Baseline on the Pediatric Migraine Disability Assessment Test (PedMIDAS) Total Score	Change from baseline on the PedMIDAS total score	Baseline, 3 Months
Pharmacokinetics (PK): Serum Concentration of Galcanezumab	PK: Serum concentration of galcanezumab	Baseline through 3 Months
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)	Plasma concentration of CGRP	Baseline through 3 Months
Percentage of Participants Developing Anti-Drug Antibodies	Percentage of participants developing anti-drug antibodies	Baseline through 3 Months
Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase	Percentage of participants who initiate migraine prevention medication in the post-treatment follow-up phase	16 Months

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2018
• Primary Completion (Actual): November 14, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: pediatric; children; prevention; prophylaxis; headache; pediatric migraine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Headache; galcanezumab
• Other Study ID Numbers: 16352; I5Q-MC-CGAS (Other Identifier: Eli Lilly and Company); 2017-004351-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No