EUCTR2015-000149-22-FI进行中(未招募)1 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients with Episodic 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
- 109
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 (or patients) 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 (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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