EUCTR2015-005234-21-NL进行中（未招募）1 期
A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (galcanezumab) in Patients with Episodic or Chronic Cluster Headache
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 324
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 304
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
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.
研究者
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