A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 40
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
研究概览
简要总结
The main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM (NCT02438826).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who participated in and completed either study CGAL or study CGAM.
- •Investigator judges the participant as reliable to follow all study procedures, keep all study visits, and be compliant with study requirements.
排除标准
- •Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device (with the exception of Study CGAL or Study CGAM).
- •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) (with the exception of Study CGAL or Study CGAM).
- •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
Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month.
干预措施: Galcanezumab (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
时间窗: Baseline through End of Study (Up to 4 Years)
A TEAE is defined as the reported AEs that first occurred or worsened during the post-baseline phase compared with the baseline phase. An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. A summary of serious and other non-serious adverse events regardless of causality is located in the reported adverse events module.
Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
时间窗: Baseline through End of Study (Up to 4 Years)
C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no). * Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent. * Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide.
次要结局
- Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab(Baseline through End of Study (Up to 4 Years))