A Study Of Galcanezumab In Participants With Episodic Cluster Headache

Phase 3

Completed

Conditions: Episodic Cluster Headache

Interventions: Drug: Placebo
Drug: Galcanezumab

Registration Number: NCT02397473

Lead Sponsor: Eli Lilly and Company

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 109

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered SC every 30 days during an 8 week treatment period.
Galcanezumab 300mg	Galcanezumab	Galcanezumab 300mg administered subcutaneously (SC) every 30 days during an 8 week treatment period.

Primary Outcome Measures

Name	Time	Method
Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks	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

Name	Time	Method
Pharmacokinetics (PK): Serum Concentration of Galcanezumab	Week 8
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)	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.
Percentage of Participants With 50% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks	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.
Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab	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.
Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks	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.
Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks	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.
Percentage of Participants With 30% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks	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.
Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)	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.
Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)	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.

Trial Locations

Locations (24): Cedars Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Stanford University Hospital
🇺🇸
Palo Alto, California, United States
California Medical Clinic for Headache
🇺🇸
Santa Monica, California, United States
Colorado Neurological Institute
🇺🇸
Englewood, Colorado, United States
New England Institute for Clinical Research
🇺🇸
Stamford, Connecticut, United States
Mayo Clinic-Jacksonville
🇺🇸
Jacksonville, Florida, United States
University of Miami
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Miami, Florida, United States
St. Anthony's Hospital
🇺🇸
Saint Petersburg, Florida, United States
Tampa General Hospital
🇺🇸
Tampa, Florida, United States
Atlanta Center of Medical Research
🇺🇸
Atlanta, Georgia, United States
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Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States