A Study Of Galcanezumab In Participants With Episodic Cluster Headache
- 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
- 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.
- 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)
New England Institute for Clinical Research
đŸ‡ºđŸ‡¸Stamford, Connecticut, United States
Dent Neurological Institute
đŸ‡ºđŸ‡¸Amherst, New York, United States
Mayo Clinic-Jacksonville
đŸ‡ºđŸ‡¸Jacksonville, Florida, United States
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
đŸ‡¨đŸ‡¦Toronto, Canada
Klinikum der Universität MĂ¼nchen Campus GroĂŸhadern
đŸ‡©đŸ‡ªMunchen, Germany
Atlanta Center of Medical Research
đŸ‡ºđŸ‡¸Atlanta, Georgia, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
đŸ‡³đŸ‡±Nijmegen, Netherlands
Cedars Sinai Medical Center
đŸ‡ºđŸ‡¸Los Angeles, California, United States
California Medical Clinic for Headache
đŸ‡ºđŸ‡¸Santa Monica, California, United States
Colorado Neurological Institute
đŸ‡ºđŸ‡¸Englewood, Colorado, United States
Stanford University Hospital
đŸ‡ºđŸ‡¸Palo Alto, California, United States
St. Anthony's Hospital
đŸ‡ºđŸ‡¸Saint Petersburg, Florida, United States
ClinVest
đŸ‡ºđŸ‡¸Springfield, Missouri, United States
Northwest Clinical Research Center
đŸ‡ºđŸ‡¸Bellevue, Washington, United States
West Virginia University Hospital
đŸ‡ºđŸ‡¸Morgantown, West Virginia, United States
Migräne- und Kopfschmerzklinik GmbH & Co. KG
đŸ‡©đŸ‡ªKonigstein, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
đŸ‡¬đŸ‡§London, United Kingdom
Uniklinikum Essen AöR
đŸ‡©đŸ‡ªEssen, Germany
University of Miami
đŸ‡ºđŸ‡¸Miami, Florida, United States
Tampa General Hospital
đŸ‡ºđŸ‡¸Tampa, Florida, United States
Michigan Head, Pain, and Neurological Institute
đŸ‡ºđŸ‡¸Ann Arbor, Michigan, United States
Clinical Trials of South Carolina
đŸ‡ºđŸ‡¸Charleston, South Carolina, United States
"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."
đŸ‡«đŸ‡·Paris, France
Thomas Jefferson University
đŸ‡ºđŸ‡¸Philadelphia, Pennsylvania, United States