NCT02397473已完成3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Cluster Headache
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 24
- 主要终点
- Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Galcanezumab 300mg
Experimental
Galcanezumab 300mg administered subcutaneously (SC) every 30 days during an 8 week treatment period.
干预措施: Galcanezumab (Drug)
Placebo
Placebo Comparator
Placebo administered SC every 30 days during an 8 week treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks
时间窗: 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.
次要结局
- 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)
研究者
研究点 (24)
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