EUCTR2014-005429-11-GR进行中（未招募）1 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 with a Long-Term Open-Label Extension in Patients with Chronic Cluster Headache - I5Q-MC-CGAM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 162
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
入选标准
- •Participants (or patients) with a history of chronic cluster headache occuring without a remission period, or with remissions lasting less than 1 month for at least 1 year.
- •Participants (or patients) are able to distinguish cluster headache
- •attacks from other headaches.
- •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 157
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
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 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.
研究者
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