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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03432286
Collaborator
(none)
325
Enrollment
77
Locations
2
Arms
69.9
Anticipated Duration (Months)
4.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
325 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study
Actual Study Start Date :
Mar 14, 2018
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Jan 9, 2024

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in the Number of Monthly Migraine Headache Days [Baseline, 3 Months]

      Change from baseline in the number of monthly migraine headache days

    Secondary Outcome Measures

    1. Percentage of Participants with Reduction from Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days [3 Months]

      Percentage of participants with reduction from baseline ≥50%, ≥75% and 100% in monthly migraine headache days

    2. 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 nausea and/or vomiting

    3. 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 headache days with photophobia and phonophobia

    4. 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 headaches with prodromal symptoms

    5. Change from Baseline in the Number of Migraine Headache Days on which Acute Headache Medication is Taken [Baseline, 3 Months]

      Change from baseline in the number of migraine headache days on which acute headache medication is taken

    6. Patient Global Impression-Improvement (PGI-I) Rating [Month 1 to Month 3]

      PGI-I rating

    7. Change from Baseline in the Severity of Remaining Migraine Headaches per Month [Baseline, 3 Months]

      Change from baseline in the severity of remaining migraine headaches per month

    8. Change from Baseline in the Number of Monthly Headache Days [Baseline, 3 Months]

      Change from baseline in the number of monthly headache days

    9. Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score [Baseline, 3 Months]

      Change from Baseline on the PedsQL total score

    10. Change from Baseline on the Pediatric Migraine Disability Assessment Test (PedMIDAS) Total Score [Baseline, 3 Months]

      Change from baseline on the PedMIDAS total score

    11. Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score [Baseline through 3 Months]

      Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the C-SSRS Score

    12. Pharmacokinetics (PK): Serum Concentration of Galcanezumab [Baseline through 3 Months]

      PK: Serum concentration of galcanezumab

    13. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [Baseline through 3 Months]

      Plasma concentration of CGRP

    14. Percentage of Participants Developing Anti-Drug Antibodies [Baseline through 3 Months]

      Percentage of participants developing anti-drug antibodies

    15. Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase [16 Months]

      Percentage of participants who initiate migraine prevention medication in the post-treatment follow-up phase

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rehabilitation & Neurological Services Huntsville Alabama United States 35805-4046
    2 21st Century Neurology, a division of Xenoscience Phoenix Arizona United States 85004
    3 Barrow Neurological Institute at Phoenix Children's Hospital Phoenix Arizona United States 85016
    4 Center for Neurosciences Tucson Arizona United States 85718
    5 MemorialCare Health System - Long Beach Medical Center Long Beach California United States 90806
    6 Orange County Research Institute - Ontario Ontario California United States 91762
    7 Medical Center For Clinical Research San Diego California United States 92120
    8 Children's Hospital Colorado Aurora Colorado United States 80045
    9 Clinical Neuroscience Solutions Inc Jacksonville Florida United States 32256
    10 Alphab Global Research Jupiter Florida United States 33458
    11 Jackson Memorial Hospital Miami Florida United States 33136
    12 Ezy Medical Research Miami Florida United States 33175
    13 Sensible Healthcare, LLC Ocoee Florida United States 34761
    14 Psychiatric Inst of Florida-Clinical Neuroscience Solutions Orlando Florida United States 32801
    15 Clinical Research Center of Florida Pompano Beach Florida United States 33060
    16 University of South Florida Tampa Florida United States 33612-4799
    17 ForCare Clinical Research Tampa Florida United States 33613
    18 Northwest Clinical Trials Boise Idaho United States 83704
    19 Advanced Clinical Research LLC Meridian Idaho United States 83642
    20 Alexian Brothers Medical Center Hoffman Estates Illinois United States 60169
    21 University of Kentucky College of Medicine Lexington Kentucky United States 40504
    22 Pharmasite Research, Inc. Baltimore Maryland United States 21208
    23 Boston Clinical Trials Boston Massachusetts United States 02131
    24 New England Neurological Associates, PC Lawrence Massachusetts United States 01843
    25 MedVadis Research Corporation Waltham Massachusetts United States 02451
    26 Minneapolis Clinic of Neurology Burnsville Minnesota United States 55337
    27 Children Mercy Pediatric Clinical Research Unit Kansas City Missouri United States 64108
    28 Dent Neurologic Institute Amherst New York United States 14226-0000
    29 Northwell Health Great Neck New York United States 11021
    30 Northwell Health- Division of Pediatric Neurology Lake Success New York United States 11042
    31 Cincinnati Childrens Hospital Medical Center Cincinnati Ohio United States 45229
    32 UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15224
    33 Preferred Primary Care Physicians Pittsburgh Pennsylvania United States 15236
    34 Velocity Clinical Research East Greenwich Rhode Island United States 02818
    35 University of Texas Southwestern Medical Center at Dallas Dallas Texas United States 75390-9063
    36 Houston Neurology Clinical & Diagnostic Consultants Houston Texas United States 77054
    37 Northwest Clinical Research Center Bellevue Washington United States 98007-4209
    38 Seattle Children's Research Institute Seattle Washington United States 98105
    39 Sanos Clinic Gandrup Gandrup North Jutland Denmark 9362
    40 Herlev Universitets Hospital Herlev Denmark 2730
    41 Praxis Dr. med. Astrid Gendolla Praxis für Neurologie, Psychosomatik,Nervenheilkunde, Psychotherapieund Spezielle Schmerztherapie Essen Nordrhein-Westfalen Germany 45133
    42 G.B. Pant Institute of Postgraduate Medical Education & Research New Delhi Delhi India 110002
    43 All India Institute of Medical Sciences New Delhi Delhi India 110029
    44 Sir Ganga Ram Hospital New Delhi Delhi India 110060
    45 Panchshil hospital Ahmedabad Gujarat India 380005
    46 Mangala Hospital & Mangala Kidney Foundation Mangalore Karnataka India 575003
    47 Getwell Hospital and Research Institute Nagpur Maharashtra India 440012
    48 All India Institute of Medical Sciences - Nagpur Nagpur Maharashtra India 441108
    49 Apollo Gleneagles Hospitals Kolkata Kolkata West Bengal India 700054
    50 Central India Cardiology and Research Institute Nagpur India 440015
    51 UOSD di Neuropsichiatria Infantile Napoli Naples Italy 80131
    52 Istituto Neurologico Carlo Besta Milano Italy 20133
    53 Ospedale Bambino Gesu Roma Italy 00165
    54 Università degli Studi di Roma La Sapienza - Policlinico Umberto I Roma Italy 00185
    55 Konan Hospital Kobe Hyogo Japan 658-0064
    56 Yamaguchi Clinic Nishinomiya Hyogo Japan 663-8204
    57 Sendai Headache and Neurology Clinic Sendai Miyagi Japan 982-0014
    58 Tokyo Medical University Hospital Shinjuku-ku Tokyo Japan 160-0023
    59 Umenotsuji Clinic Kochi Japan 780-8011
    60 Tatsuoka Neurology Clinic Kyoto Japan 600-8811
    61 Tominaga Hospital Osaka Japan 556-0017
    62 Tokyo Headache Clinic Tokyo Japan 151-0051
    63 Hospital Infantil de Mexico Federico Gomez Ciudad de Mexico Federal District Mexico 06720
    64 Hospital Civil Fray Antonio Alcalde Guadalajara Jalisco Mexico 44280
    65 PanAmerican Clinical Research S.A.de C.V. Guadalajara Guadalajara JA Mexico 44670
    66 Clinica De Enfermedades Cronicas y Procedimientos Especiales Morelia Michoacan Mexico 58249
    67 Centro de Investigacion Medica Aguascalientes Aguascalientes Mexico 20116
    68 Unidad de Investigación en Salud Chihuahua Mexico 31203
    69 Isala, locatie Zwolle Zwolle Overijssel Netherlands 8025 AB
    70 Dr. Samuel Sanchez PSC Caguas Puerto Rico 00727
    71 Ponce School of Medicine CAIMED Center Ponce Puerto Rico 00716
    72 Barbara Diaz Hernandez San Juan Puerto Rico 00927
    73 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025
    74 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    75 Hospital Universitario Virgen Del Rocio Sevilla Spain 41013
    76 Hospital Clínico Universitario de Valencia Valencia Spain 46010
    77 Hospital Clinico Universitario de Valladolid Valladolid Spain 47010

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03432286
    Other Study ID Numbers:
    • 16352
    • I5Q-MC-CGAS
    • 2017-004351-23
    First Posted:
    Feb 14, 2018
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 15, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    pediatric
    children
    prevention
    prophylaxis
    headache
    pediatric migraine
    Additional relevant MeSH terms:
    Migraine Disorders

    Study Results

    No Results Posted as of Aug 18, 2022