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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 : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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
Episodic Migraine Drug: Galcanezumab Drug: Placebo 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 14, 2018
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : January 9, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

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

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

  14. Percentage of Participants Developing Anti-Drug Antibodies [ Time Frame: 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 [ Time Frame: 16 Months ]
    Percentage of participants who initiate migraine prevention medication in the post-treatment follow-up phase


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432286


Contacts
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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

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03432286    
Other Study ID Numbers: 16352
I5Q-MC-CGAS ( Other Identifier: Eli Lilly and Company )
2017-004351-23 ( EudraCT Number )
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 1, 2021
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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/

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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:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases