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临床试验/EUCTR2015-000149-22-FI
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

Eli Lilly and Company0 个研究点目标入组 109 人开始时间: 2015年4月24日最近更新:
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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