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

February 25, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9362
        • Sanos Clinic - Nordjylland
      • Copenhagen, Denmark, 2730
        • Herlev and Gentofte Hospital
  • France
      • Amiens, France, 80054
        • CHU d'Amiens-Picardie - Hôpital Sud
      • Bordeaux, France, 33076
        • Bordeaux University Hospital - Pellegrin
      • Créteil, France, 94010
        • Centre Hospitalier Intercommunal de Créteil
      • Lille, France, 59037
        • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
      • Marseille, France, 13385
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
      • Paris, France, 75571
        • Hopital Armand Trousseau
  • Germany
      • Essen, Germany, 45133
        • Praxis Dr. Astrid Gendolla
  • India
      • Ahmedabad, India, 382428
        • Apollo Hospitals Ahmedabad
      • Gurugram, India, 122003
        • Artemis hospital
      • Kanpur, India, 208011
        • Atmaram Child Care
      • Mangalore, India, 575003
        • Mangala Hospital & Mangala Kidney Foundation
      • Nagpur, India, 440015
        • Central India Cardiology and Research Institute
      • Nagpur, India, 440012
        • Getwell Hospital and Research Institute
      • Nagpur, India, 441108
        • Department of Pediatrics
      • 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, 161
        • Policlinico Umberto I
      • Roma, Italy, 165
        • Neuroscience
  • Japan
      • Kagoshima, Japan, 892-0844
        • Tanaka Neurosurgery&Headache Clinic
      • 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
      • 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
      • Mexico City, Mexico, 6720
        • Hospital Infantil de Mexico Federico Gomez
      • Morelia, Mexico, 58249
        • Clinica De Enfermedades Cronicas y Procedimientos Especiales
  • Netherlands
      • Zwolle, Netherlands, 8025 AB
        • Isala, locatie Zwolle
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce Medical School Foundation Inc.
  • Spain
      • Barcelona, Spain
        • 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 Clínico 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
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Northwest Florida Clinical Research Group
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
      • Miami, Florida, United States, 33155
        • Allied Biomedical Research Institute
      • Miami, Florida, United States, 33144
        • Bio-Medical Research LLC
      • Miami, Florida, United States, 33125
        • Vitaly Clinical Research
      • Miami, Florida, United States, 33126
        • EMDA Clinical Research
      • Miami Lakes, Florida, United States, 33016
        • Wellness Clinical Research
      • Miami Lakes, Florida, United States, 33015
        • Ezy Medical Research
      • Pensacola, Florida, United States, 32503
        • Avanza Medical Research Center
      • Tamarac, Florida, United States, 33321
        • D&H Tamarac Research Center
      • Tamarac, Florida, United States, 33321
        • Infinity Life Research Group
      • Tampa, Florida, United States, 33612
        • USF Health
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Idaho
      • Ammon, Idaho, United States, 83406
        • Medical Research Partners
      • Boise, Idaho, United States, 83704
        • Northwest Clinical Trials
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • St. Alexius Medical Center
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Ascension via Christi Research
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Pharmasite Research, Inc.
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • MedVadis Research Corporation
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Minneapolis Clinic of Neurology - Burnsville Office
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Research Centers
      • Ridgeland, Mississippi, United States, 39157
        • Proven Endpoints
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children Mercy Pediatric Clinical Research Unit
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peter's University Hospital
    • 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
      • Cincinnati, Ohio, United States, 45236
        • Headache Center of Hope
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Health & Services
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • UPMC Children's Hospital of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Coastal Pediatric Research
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Access Clinical Trials - Nashville
    • Texas
      • Dallas, Texas, United States, 75235
        • UT Southwestern Medical Center
      • Lewisville, Texas, United States, 75067
        • Prime Clinical Research - Lewisville
    • Utah
      • Logan, Utah, United States, 84341
        • Medical Research Partners - Logan
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

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.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline, 3 Months
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 Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
Time Frame: 3 Months
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
Time Frame: Baseline, 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, 3 Months
Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken
Baseline, 3 Months
Patient Global Impression-Improvement (PGI-I) Rating
Time Frame: Month 1 to Month 3
PGI-I Rating
Month 1 to Month 3
Change from Baseline in the Severity of Remaining Migraine Headaches per Month
Time Frame: Baseline, 3 Months
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
Time Frame: Baseline, 3 Months
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
Time Frame: Baseline, 3 Months
Change from Baseline on the PedsQL Total Score
Baseline, 3 Months
Change from Baseline on the Pediatric Migraine Disability Assessment test (PedMIDAS) Total Score
Time Frame: Baseline, 3 Months
Change from Baseline on the PedMIDAS Total Score
Baseline, 3 Months
Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time Frame: Baseline through 3 Months
Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the C-SSRS Score
Baseline through 3 Months
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Time Frame: Baseline through 3 Months
PK: Serum Concentration of Galcanezumab
Baseline through 3 Months
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Time Frame: Baseline through 3 Months
Plasma Concentration of CGRP
Baseline through 3 Months
Percentage of Participants Developing Anti-Drug Antibodies
Time Frame: Baseline through 3 Months
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
Time Frame: 16 Months
Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase
16 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

November 25, 2020

Primary Completion (Actual)

December 10, 2025

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16353
  • 2018-004622-28 (EudraCT Number)
  • I5Q-MC-CGAT (Other Identifier: Eli Lilly and Company)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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