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: 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 (Estimated): 325
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: ClinicalTrials.gov@lilly.com

Study Locations

• Denmark
  • Hovedstaden
    • Copenhagen, Hovedstaden, Denmark, 2730
      • Recruiting
      • Herlev and Gentofte Hospital
      • Principal Investigator: Nanette Debes
  • Nordjylland
    • Aalborg, Nordjylland, Denmark, 9362
      • Recruiting
      • Sanos Clinic - Nordjylland
      • Principal Investigator: Helene Rovsing
• Germany
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45133
      • Completed
      • Praxis Dr. med. Astrid Gendolla Praxis für Neurologie, Psychosomatik,Nervenheilkunde, Psychotherapieund Sp -T
• India
  • Delhi
    • New Delhi, Delhi, India, 110060
      • Recruiting
      • Sir Ganga Ram Hospital
      • Principal Investigator: Rohtagi Anshu
    • New Delhi, Delhi, India, 110029
      • Recruiting
      • All India Institute of Medical Sciences
      • Principal Investigator: Sheffali Gulati
    • New Delhi, Delhi, India, 110002
      • Recruiting
      • G.B. Pant Institute of Postgraduate Medical Education & Research
      • Principal Investigator: Debashish Chowdhury
  • Karnataka
    • Mangalore, Karnataka, India, 575003
      • Recruiting
      • Mangala Hospital & Mangala Kidney Foundation
      • Principal Investigator: Shankara Nellikunja
  • Maharashtra
    • Nagpur, Maharashtra, India, 440015
      • Recruiting
      • Central India Cardiology and Research Institute
      • Principal Investigator: Amarjeet Wagh
    • Nagpur, Maharashtra, India, 440012
      • Recruiting
      • Lillestol Research
      • Principal Investigator: Prafulla Keshaorao Shembalkar
    • Nagpur, Maharashtra, India, 441108
      • Recruiting
      • All India Institute of Medical Sciences (AIIMS) - Nagpur
      • Principal Investigator: Meenakshi Girish
    • Pune, Maharashtra, India, 411007
      • Recruiting
      • Medipoint Hospitals Pvt. Ltd.
      • Principal Investigator: Pramod Jog
• Italy
  • Roma, Italy, 00165
    • Not yet recruiting
    • Ospedale Pediatrico Bambino Gesu
    • Principal Investigator: Massimiliano Valeriani
  • Campania
    • Napoli, Campania, Italy, 80131
      • Recruiting
      • Università degli Studi della Campania Luigi Vanvitelli
      • Principal Investigator: Marco Carotenuto
  • Lazio
    • Roma, Lazio, Italy, 161
      • Recruiting
      • Policlinico Umberto I
      • Principal Investigator: paola verdecchia
  • Lombardia
    • Milano, Lombardia, Italy, 20133
      • Recruiting
      • IRCCS Istituto Neurologico Carlo Besta
      • Principal Investigator: licia grazzi
• Japan
  • Kochi, Japan, 780-8011
    • Recruiting
    • Umenotsuji Clinic
    • Principal Investigator: Hiroshi Yamada
  • Kyoto, Japan, 600-8811
    • Recruiting
    • Tatsuoka Neurology Clinic
    • Principal Investigator: Yoshihisa Tatsuoka
  • Osaka, Japan, 556-0017
    • Recruiting
    • Tominaga Hospital
    • Contact: Phone Number: 81120023812
    • Principal Investigator: Takao Takeshima
  • Hyogo
    • Kobe, Hyogo, Japan, 658-0064
      • Recruiting
      • Konan Hospital
      • Principal Investigator: Shigekazu Kitamura
    • Nishinomiya, Hyogo, Japan, 663-8204
      • Recruiting
      • Yamaguchi Clinic
      • Principal Investigator: Michio Yamaguchi
  • Miyagi
    • Sendai, Miyagi, Japan, 982-0014
      • Recruiting
      • Sendai Headache and Neurology Clinic
      • Principal Investigator: Yasuhiko Matsumori
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Recruiting
      • Tokyo Medical University Hospital
      • Principal Investigator: Gaku Yamanaka
• Mexico
  • Aguascalientes, Mexico, 20116
    • Recruiting
    • Centro de Investigacion Medica Aguascalientes
    • Principal Investigator: Sarug Reyes Morales
  • Chihuahua, Mexico, 31203
    • Recruiting
    • Unidad de Investigación en Salud
    • Principal Investigator: Avril Molina Garcia
  • Mexico City, Mexico, 6720
    • Recruiting
    • Hospital Infantil de Mexico Federico Gomez
    • Principal Investigator: Juan Carlos García Beristain
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Recruiting
      • Hospital Civil Fray Antonio Alcalde
      • Principal Investigator: Hugo Ceja Moreno
    • Guadalajara, Jalisco, Mexico, 44670
      • Recruiting
      • PanAmerican Clinical Research - Guadalajara
      • Principal Investigator: Ixiu del Carmen Cabrales Guerra
  • Michoacan
    • Morelia, Michoacan, Mexico, 58249
      • Recruiting
      • Clinica De Enfermedades Cronicas y Procedimientos Especiales
      • Contact: Phone Number: 524433232828
      • Principal Investigator: Carlos Toledo
• Netherlands
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025 AB
      • Recruiting
      • Isala, locatie Zwolle
      • Principal Investigator: Jolita Bekhof
• Puerto Rico
  • Caguas, Puerto Rico, 727
    • Recruiting
    • Dr. Samuel Sanchez PSC
    • Principal Investigator: Karen Cruz
  • Ponce, Puerto Rico, 00716
    • Recruiting
    • Ponce Medical School Foundation Inc.
    • Principal Investigator: Odette Olivieri Ramos
  • San Juan, Puerto Rico, 926
    • Recruiting
    • Barbara Diaz-Hernandez MD Research, Inc.
    • Principal Investigator: Ileana M Fumero-Perez
• Spain
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
    • Principal Investigator: carmen Gonzalez oria
  • Valladolid, Spain, 47005
    • Recruiting
    • Hospital Clínico Universitario de Valladolid
    • Principal Investigator: Ángel Guerrero Peral
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 8035
      • Recruiting
      • Hospital Universitari Vall d'Hebron
      • Principal Investigator: Patricia Pozo-Rosich
    • Barcelona, Barcelona [Barcelona], Spain, 8041
      • Recruiting
      • Hospital de la Santa Creu i Sant Pau
      • Principal Investigator: Roberto Belvis Nieto
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46010
      • Recruiting
      • Hospital Clínico de Valencia
      • Principal Investigator: Jose Miguel Lainez
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Recruiting
      • Rehabilitation & Neurological Services
      • Principal Investigator: Belinda Savage-Edwards, MD
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Phoenix Children'S Hospital
      • Principal Investigator: Robert Little
    • Phoenix, Arizona, United States, 85004
      • Completed
      • Xenoscience
    • Tucson, Arizona, United States, 85718
      • Recruiting
      • Center for Neurosciences
      • Principal Investigator: Dinesh Talwar
  • California
    • Long Beach, California, United States, 90806
      • Recruiting
      • Miller Children's & Women's Hospital Long Beach
      • Principal Investigator: Jasmin Dao
    • Ontario, California, United States, 91762
      • Recruiting
      • Orange County Research Institute
      • Principal Investigator: Rosario Retino
    • San Diego, California, United States, 92108
      • Completed
      • Wr-McCr, Llc
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Principal Investigator: Marcy Yonker
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
      • Principal Investigator: Nandita Jones
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Don Suffer Clinical Research Building
      • Principal Investigator: Danielle Horn
    • Miami, Florida, United States, 33175
      • Recruiting
      • Ezy Medical Research
      • Principal Investigator: Jorge Paoli-Bruno
    • Ocoee, Florida, United States, 34761
      • Recruiting
      • Sensible Healthcare, LLC
      • Principal Investigator: Kelly Nanette Taylor
    • Orlando, Florida, United States, 32801
      • Completed
      • Clinical Neuroscience Solutions
    • Pensacola, Florida, United States, 32503
      • Recruiting
      • Avanza Medical Research Center
      • Principal Investigator: Randall E Reese
    • Tampa, Florida, United States, 33613
      • Recruiting
      • Forcare Clinical Research
      • Principal Investigator: Seth Benjamin Forman
    • Tampa, Florida, United States, 33612
      • Recruiting
      • USF Health
      • Principal Investigator: Janice Yvonne Maldonado
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Rare Disease Research, LLC
      • Principal Investigator: Han Phan
    • Savannah, Georgia, United States, 31406
      • Recruiting
      • Meridian Clinical Research, LLC
      • Principal Investigator: Katherine McNaughton Moretz
  • Idaho
    • Ammon, Idaho, United States, 83406
      • Recruiting
      • Medical Research Partners
      • Principal Investigator: Joseph Reed Moore
    • Blackfoot, Idaho, United States, 83221
      • Recruiting
      • Elite Clinical Trials
      • Principal Investigator: Gary Soucie
    • Boise, Idaho, United States, 83704
      • Recruiting
      • Northwest Clinical Trials
      • Principal Investigator: Brock Aaron McConnehey
    • Meridian, Idaho, United States, 83642
      • Recruiting
      • Velocity Clinical Research, Boise
      • Principal Investigator: Mark Alan Turner
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Recruiting
      • St. Alexius Medical Center
      • Principal Investigator: Abdul Mazin
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Recruiting
      • College Park Specialty Center
      • Principal Investigator: Jeffrey Kaplan
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky Chandler Medical Center
      • Principal Investigator: Sharoon Qaiser
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Recruiting
      • Pharmasite Research, Inc.
      • Principal Investigator: Sarah Herts
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Recruiting
      • Boston Clinical Trials
      • Principal Investigator: Antonio Mendes
    • Methuen, Massachusetts, United States, 01844
      • Recruiting
      • ActivMed Practices and Research
      • Principal Investigator: Andreas Shoeck
    • Waltham, Massachusetts, United States, 02451
      • Recruiting
      • MedVadis Research Corporation
      • Principal Investigator: David DiBenedetto
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Recruiting
      • Minneapolis Clinic of Neurology - Burnsville Office
      • Principal Investigator: Rajiv Aggarwal
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Completed
      • Children's Mercy Hospital
  • New York
    • Amherst, New York, United States, 14226
      • Recruiting
      • Dent Neurologic Institute
      • Principal Investigator: Jennifer McVige
    • Great Neck, New York, United States, 11021
      • Recruiting
      • Northwell Health
      • Principal Investigator: Robert Duarte
    • New Hyde Park, New York, United States, 11042
      • Recruiting
      • Cohen Children's Northwell Health Physician Partners - Pediatric Neurology
      • Principal Investigator: Ivan Pavkovic
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • Velocity Clinical Research at Raleigh Neurology
      • Principal Investigator: Leslie Boyce
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Principal Investigator: marielle kabbouche Samaha
  • Oregon
    • Portland, Oregon, United States, 97225
      • Recruiting
      • Providence Health & Services
      • Principal Investigator: Alison Christy
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • UPMC Children's Hospital of Pittsburgh
      • Principal Investigator: Catalina Cleves-Bayon
    • Pittsburgh, Pennsylvania, United States, 15236
      • Completed
      • Office 18
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Recruiting
      • Velocity Clinical Research, Providence
      • Principal Investigator: David L. Fried
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Recruiting
      • Tribe Clinical Research, LLC
      • Principal Investigator: Scott Robert Dobson, MD
  • Texas
    • Houston, Texas, United States, 77054
      • Recruiting
      • Pain and Headache Centers of Texas
      • Principal Investigator: Monika Ummat
  • Washington
    • Bellevue, Washington, United States, 98007
      • Recruiting
      • Northwest Clinical Research Center
      • Principal Investigator: Arifulla Khan, MD
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital
      • Principal Investigator: Heidi Blume

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 9 AM - 5 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 (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 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): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; children; prevention; prophylaxis; headache; pediatric migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• 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