A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Cluster Headache

Eli Lilly and Company24 sites in 6 countries109 target enrollmentMay 22, 2015

ConditionsEpisodic Cluster Headache

InterventionsGalcanezumab Placebo

DrugsGalcanezumab Placebo

Overview

Phase: Phase 3
Intervention: Galcanezumab
Conditions: Episodic Cluster Headache
Sponsor: Eli Lilly and Company
Enrollment: 109
Locations: 24
Primary Endpoint: Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 22, 2015

End Date

June 4, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

Galcanezumab 300mg

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

Intervention: Galcanezumab

Placebo

Placebo administered SC every 30 days during an 8 week treatment period.

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

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)
Percentage of Participants With 50% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks(Baseline, Week 1 through Week 8)
Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab(Baseline through Week 8)
Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks(Baseline, Week 3)
Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks(Baseline, Week 1 through Week 8)
Percentage of Participants With 30% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks(Baseline, Week 1 through Week 8)
Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)(Month 1 through Month 6)
Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)(Month 1 through Month 6)