A Study of Galcanezumab in Participants With Chronic Cluster Headache

Eli Lilly and Company240 enrolled

Overview

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

240

Conditions

Chronic Cluster Headache

Interventions

Galcanezumab 300 mgDRUG

Administered SC

PlaceboDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants with a history of chronic cluster headache occurring without a remission period, or with remissions lasting \<1 month, for at least 1 year. * 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.

Locations (48)

Outcomes

Primary Outcomes

Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency

Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 12 weeks of daily data during double-blind treatment phase will be converted into 14-calendar day intervals: the baseline 14-day interval, Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Next, the biweekly interval results were adjusted to 7-day (weekly) interval in order to report the outcome as weekly frequency. Overall mean change from baseline is derived from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, verapamil use, pooled investigative site, week, baseline, and treatment by week as fixed effects.

Time frame: Baseline, Week 1 through Week 12

Secondary Outcomes

Percentage of Participants With a 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks

A 50% responder is any participant who has a ≥50% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval: Weeks 1/2, Weeks 3/4, Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects.

Time frame: Baseline, Week 1 through Week 12

Percentage of Participants With a Sustained Response of 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks

Sustained Response is defined as a 50% or greater reduction in the weekly cluster attack frequency from baseline to Weeks 3/4 and maintained at Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Percentage of participants with a sustained response 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, verapamil use and baseline value.

Time frame: Baseline, Week 3 through Week 12

Data from ClinicalTrials.gov

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Mayo Clinic Hospital

Phoenix, Arizona, United States

California Medical Clinic for Headache

Santa Monica, California, United States

Stanford University Hospital

Stanford, California, United States

Colorado Neurological Institute

Englewood, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Yale University School of Medicine

New Haven, Connecticut, United States

New England Institute for Clinical Research

Stamford, Connecticut, United States

Mayo Clinic-Jacksonville

Jacksonville, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Michigan Head, Pain and Neurological Institute

Ann Arbor, Michigan, United States

...and 38 more locations

Percentage of Participants With a 30% Reduction in the Weekly Number of Cluster Headache Attacks

A 30% responder is any participant who has a ≥30% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval. Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects. .

Time frame: Baseline, Week 1 through Week 12

Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)

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, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.

Time frame: Week 4

Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)

Time frame: Week 8

Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)

Time frame: Week 12

Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)

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.

Time frame: Week 1 through Week 12

Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)

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.

Time frame: Week 1 through Week 12

Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab (LY2951742)

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.

Time frame: Baseline, Week 1 through Week 12

Pharmacokinetics (PK): Serum Concentration of Galcanezumab

Time frame: Week 2

Pharmacokinetics (PK): Serum Concentration of Galcanezumab

Time frame: Week 4

Pharmacokinetics (PK): Serum Concentration of Galcanezumab

Time frame: Week 8

Pharmacokinetics (PK): Serum Concentration of Galcanezumab

Time frame: Week 12