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临床试验/NCT01495715
NCT01495715撤回3 期

Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)

Santhera Pharmaceuticals0 个研究点开始时间: 2011年12月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
撤回

研究概览

简要总结

The objective of the study is to determine whether administration of idebenone can shorten the time to improvement of visual acuity in patients with chronic vision loss due to LHON.

研究设计

研究类型
Interventional

入排标准

年龄范围
10 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > or equal 10 years and < 65 years
  • Impaired visual acuity in affected eyes due to LHON: Visual acuity in best eye >0.4 logMAR
  • No explanation for visual loss besides LHON

排除标准

  • Any previous use of idebenone
  • Participation in another clinical trial of any investigational drug within 3 months prior to Baseline
  • Previous participation in Study SNT-II-003 (RHODOS) for idebenone.

研究组 & 干预措施

Idebenone

Experimental

干预措施: Idebenone (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

研究者

申办方类型
Industry
责任方
Sponsor

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