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A Study Of Galcanezumab In Participants With Episodic Cluster Headache

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02397473
Recruitment Status : Completed
First Posted : March 25, 2015
Results First Posted : March 13, 2019
Last Update Posted : September 9, 2019
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 evaluate the efficacy and safety of the study drug known as Galcanezumab in participants with episodic cluster headaches.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Cluster Headache
Actual Study Start Date : May 22, 2015
Actual Primary Completion Date : February 12, 2018
Actual Study Completion Date : June 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arms and Interventions
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Arm Intervention/treatment
Experimental: Galcanezumab 300mg
Galcanezumab 300mg administered subcutaneously (SC) every 30 days during an 8 week treatment period.
 Drug: Galcanezumab
Administered SC
Other Name: LY2951742
Placebo Comparator: Placebo
Placebo administered SC every 30 days during an 8 week treatment period.
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks [ Time Frame: Baseline, Week 1 through Week 3 ]
    Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Overall mean change from baseline is derived from the average of weeks 1 to 3 from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, pooled investigative site, week, baseline, and treatment by week as fixed effects.


Secondary Outcome Measures :
  1. Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks [ Time Frame: Baseline, Week 3 ]
    Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Percentage of participants with 50% or greater reduction from baseline at week 3 was analyzed using Koch's nonparametric randomization-based analysis of covariance method. This method adjusted for pooled investigative site by including it as a stratification variable. It also adjusted for sex and baseline value.

  2. Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks [ Time Frame: Baseline, Week 1 through Week 8 ]
    Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Overall mean change from baseline is derived from the average of weeks 1 to 8 from MMRM analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, pooled investigative site, week, baseline, and treatment by week as fixed effects.

  3. Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) [ Time Frame: Week 4 ]
    PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, baseline cluster headache attack category, month, and treatment by month as fixed effects.

  4. Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) [ Time Frame: Week 8 ]
    PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, baseline cluster headache attack category, month, and treatment by month as fixed effects.

  5. Percentage of Participants With 50% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks [ Time Frame: Baseline, Week 1 through Week 8 ]
    Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Mean percentage of participants is derived from the average of weeks 1 to 8 from generalized linear mixed model repeated measures method with treatment, sex, week, treatment by week, and baseline as fixed effects.

  6. Percentage of Participants With 30% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks [ Time Frame: Baseline, Week 1 through Week 8 ]
    Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Mean percentage of participants is derived from the average of weeks 1 to 8 from generalized linear mixed model repeated measures with treatment, sex, week, treatment by week and baseline as fixed effects.

  7. Pharmacokinetics (PK): Serum Concentration of Galcanezumab [ Time Frame: Week 4 ]
  8. Pharmacokinetics (PK): Serum Concentration of Galcanezumab [ Time Frame: Week 8 ]
  9. Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab [ Time Frame: Baseline through Week 8 ]
    Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer >= 1: 20.

  10. Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Month 1 through Month 6 ]
    C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation: a "yes" answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.

  11. Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Month 1 through Month 6 ]
    C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of cluster headache as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines with a history of episodic cluster headache with at least two cluster periods lasting from 7 days to 1 year (when untreated) and separated by pain-free remission periods of >=1 month.
  • Participants are able to distinguish cluster headache attacks from other headaches.

Exclusion Criteria:

  • Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.
  • Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
  • Are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia.
  • A history of migraine variants that could implicate or could be confused with ischemia.
  • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.
  • A history or presence of other medical illness that indicates a medical problem that would preclude study participation.
  • Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator.
  • Women who are pregnant or nursing.
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): NCT02397473


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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Statistical Analysis Plan  [PDF] April 5, 2018
Study Protocol  [PDF] March 29, 2018

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02397473    
Other Study ID Numbers: 15780
I5Q-MC-CGAL ( Other Identifier: Eli Lilly and Company )
2015-000149-22 ( EudraCT Number )
First Posted: March 25, 2015    Key Record Dates
Results First Posted: March 13, 2019
Last Update Posted: September 9, 2019
Last Verified: August 2019
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
Additional relevant MeSH terms:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
 Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases