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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03432286
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to determine the safety and efficacy of the study drug galcanezumab in participants 6 to 17 years of age with episodic migraine.

Condition or disease Intervention/treatment Phase
Episodic Migraine Drug: Galcanezumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 645 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 Study
Actual Study Start Date : March 14, 2018
Estimated Primary Completion Date : July 4, 2022
Estimated Study Completion Date : July 29, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Galcanezumab PK Lead-In
Galcanezumab administered by subcutaneous (SQ) injection.
Drug: Galcanezumab
Administered SQ
Other Name: LY2951742

Experimental: Galcanezumab
Galcanezumab administered by SQ injection.
Drug: Galcanezumab
Administered SQ
Other Name: LY2951742

Placebo Comparator: Placebo
Placebo administered by SQ injection.
Drug: Placebo
Administered SQ




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. 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

  2. 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

  3. 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

  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 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

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

  7. 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

  8. 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

  9. 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

  10. 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

  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. Proportion of Participants who Initiate Migraine Prevention Medication [ Time Frame: 16 Months ]
    Proportion of participants who initiate migraine prevention medication



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 as defined by the International Headache Society International Classification of Headache Disorders (IHS ICHD-3) beta guidelines (1.1 or 1.2) (ICHD-3 2013), 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 beta.
  • History of any type of headache except for migraine, tension type headache, or medication overuse headache, as defined by IHS ICHD-3 beta, in the 3 months prior to randomization. For example, a history of post-traumatic headache in this 3-month period would not be allowed.
  • History of traumatic head injury, 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.

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
Show Show 39 study locations
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
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: March 17, 2020
Last Verified: March 1, 2020
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
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases