DRKS00005271已完成3 期
Sustained-release 4-aminopyridine (Fampyra®) in the treatment of cerebellar ataxia - FACEG
Klinikum der Universität München, Campus Großhadern0 个研究点目标入组 75 人开始时间: 2013年10月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Patients male or female, aged between 18 and 80 years
- •- Clinical evaluated diagnosis of cerebellar ataxia with at least 2 points in the subscore gait of the scale for the assessment and rating of ataxia (SARA)
- •- Written informed consent of the subject
- •- Subjects, with the ability to follow study instructions and likely to attend and complete all required visits
排除标准
- •- Body weight 40 kg or less
- •- Pregnancy or breast-feeding
- •- Treatment with inhibitors of organic cation transporter 2 (OCT2), e.g. cimetidine
- •- Cardiovascular diseases e.g. recent heart attack (within the last 3 months), cardiac arrhythmia (QTc interval > 500 ms, atrial fibrillation, AV block grade = II), unstable angina pectoris, severe heart failure (NYHA class IV)
- •- Recently occurred stroke (within the last 3 months)
- •- Epileptic seizure currently or in the past
- •- Asthma (severity = grade III according to the Leitlinien des Programm für Nationale Versorgungsleitlinien)
- •- Mild or severe renal failure (Creatinine Clearance = 80ml/min)
- •- Unadjusted thyroid dysfunction
- •- Acute gastric and intestinal ulcer
- •- Other acute, serious illness of the subject
- •- Subject is unable to understand the scope, significance and consequences of this clinical trial and is unable to comply with the study design
- •- Previous participation in this clinical trial or participation in any clinical trial taking an investigational medicinal product within 30 days prior to participation in this clinical trial
研究者
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