跳至主要内容
临床试验/EUCTR2014-005429-11-FI
EUCTR2014-005429-11-FI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

Eli Lilly and Company0 个研究点目标入组 162 人开始时间: 2015年6月15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
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 chronc 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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