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

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ClinicalTrials.gov Identifier: NCT03432286
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE February 8, 2018
First Posted Date  ICMJE February 14, 2018
Last Update Posted Date May 5, 2021
Actual Study Start Date  ICMJE March 14, 2018
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2020)
  • Percentage of Participants with Reduction from Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days [ Time Frame: 3 Months ]
    Percentage of participants with reduction from baseline ≥50%, ≥75% and 100% in monthly migraine headache days
  • 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
  • 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
  • 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
  • Change from Baseline in the Number of Migraine Headache Days on which Acute Headache Medication is Taken [ Time Frame: Baseline, 3 Months ]
    Change from baseline in the number of migraine headache days on which acute headache medication is taken
  • Patient Global Impression-Improvement (PGI-I) Rating [ Time Frame: Month 1 to Month 3 ]
    PGI-I rating
  • 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
  • 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
  • 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
  • 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
  • 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
  • Pharmacokinetics (PK): Serum Concentration of Galcanezumab [ Time Frame: Baseline through 3 Months ]
    PK: Serum concentration of galcanezumab
  • Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [ Time Frame: Baseline through 3 Months ]
    Plasma concentration of CGRP
  • Percentage of Participants Developing Anti-Drug Antibodies [ Time Frame: Baseline through 3 Months ]
    Percentage of participants developing anti-drug antibodies
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
  • Proportion of Participants with Reduction from Baseline ≥50% in Monthly Migraine Headache Days [ Time Frame: 3 Months ]
    Proportion of participants with reduction from baseline ≥50% in monthly migraine headache days
  • Change from Baseline in the Number of Monthly Headache Days with Nausea and/or Vomiting [ Time Frame: Baseline, 3 Months ]
    Change from baseline in the number of monthly headache days with nausea and/or vomiting
  • Change from Baseline in the Number of Monthly Headache Days with Photophobia and Phonophobia [ Time Frame: Baseline, 3 Months ]
    Change from baseline in the number of monthly headache days with photophobia and phonophobia
  • 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
  • Change from Baseline in the Number of Days on Which Acute Migraine Treatments are Taken per Month [ Time Frame: Baseline, 3 Months ]
    Change from baseline in the number of days on which acute migraine treatments are taken per month
  • Patient Global Impression-Improvement (PGI-I) Rating [ Time Frame: 3 Months ]
    PGI-I rating
  • 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
  • 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
  • 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
  • Change from Baseline on the Patient Satisfaction with Medication Questionnaire-Modified (PSMQ-M) [ Time Frame: Baseline, 3 Months ]
    Change from baseline on the PSMQ-M
  • 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
  • Pharmacokinetics (PK): Serum Concentration of Galcanezumab [ Time Frame: Baseline through 3 Months ]
    PK: Serum concentration of galcanezumab
  • Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [ Time Frame: Baseline through 3 Months ]
    Plasma concentration of CGRP
  • Percentage of Participants Developing Anti-Drug Antibodies [ Time Frame: Baseline through 3 Months ]
    Percentage of participants developing anti-drug antibodies
  • Proportion of Participants who Initiate Migraine Prevention Medication [ Time Frame: 16 Months ]
    Proportion of participants who initiate migraine prevention medication
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Episodic Migraine
Intervention  ICMJE
  • Drug: Galcanezumab
    Administered SQ
    Other Name: LY2951742
  • Drug: Placebo
    Administered SQ
Study Arms  ICMJE
  • Experimental: Galcanezumab

    Galcanezumab administered by SQ injection.

    Participants may be eligible for optional open-label extension at the end of the double-blind period.

    Intervention: Drug: Galcanezumab
  • 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.

    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2020)
325
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2018)
274
Estimated Study Completion Date  ICMJE January 9, 2024
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, other than antibodies to calcitonin gene-related peptide (CGRP) or its receptor, is allowed if that use was more than 12 months prior to baseline.
  • Known hypersensitivity to multiple drugs, 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 persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine) as defined by IHS ICHD-3.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com
Listed Location Countries  ICMJE Denmark,   Germany,   India,   Italy,   Japan,   Mexico,   Puerto Rico,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03432286
Other Study ID Numbers  ICMJE 16352
I5Q-MC-CGAS ( Other Identifier: Eli Lilly and Company )
2017-004351-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (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.
URL: https://vivli.org/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 1, 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP