NL-OMON32601已完成3 期
A Phase III Open-Label, Single-Group, Extension Study to Obtain Long-Term Safety and Tolerability Data of Idebenone in the Treatment of Friedreich*s Ataxia Patients - Idebenone (Extension)
Santhera Pharmaceuticals (Switzerland) Limited0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •- Completion of 52 weeks in study SNT-III-001
- •- Body weight >= 25kg
- •- Negative urine pregnancy test
- •- Eligibility to participate in the present extension study as confirmed by the
- •investigator
排除标准
- •- Safety or tolerability issues arising during the course of SNT-III-001 which in
- •the opinion of the investigator preclude further treatment with idebenone
- •- Clinically significant abnormalities of haematology or biochemistry including,
- •but not limited to, elevations greater than 1.5 times the upper limit of SGOT,
- •SGPT or creatinine
- •- Parallel participation in another clinical drug trial
- •- Pregnancy or breast-feeding
- •- Abuse of drugs or alcohol
研究者
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