EUCTR2012-005312-26-DE进行中（未招募）1 期
Sustained release 4-aminopyridine (Fampyra®) in cerebellar gait disorder
Hospital of the University of Munich, Grosshadern0 个研究点开始时间: 2013年1月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Subjects will only be included in the study if they meet all of the following criteria:
- •1. Patients male or female, aged between 18 and 80 years
- •2. Clinical evaluated diagnosis of cerebellar ataxia with at least 2 points in the scale for the assessment and rating of ataxia (SARA)
- •3. Written informed consent of the subject
- •4. Subjects, with the ability to follow study instructions and likely to attend and complete all required visits (Compliance).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will not be included in the study if any of the following criteria applies:
- •1. Weight of 40 kg or less
- •2. Pregnancy or breast-feeding
- •3. Concurrend treatment with inhibitors of organic cation transporter 2 (OCT2), e.g. cimetidine
- •4. 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 (chest tightness due to impaired blood flow to the heart), severe heart failure (NYHA class IV)
- •5. Recently occurred stroke (within the last 3 months)
- •6. Epileptic seizure currently or in the past
- •7. Severe arterial hypertension (grade III according to the guidelines of the German society of cardiology, 2008)
- •8. Liver insufficiency (e.g. cirrhosis of the liver)
- •9. Asthma (severity = grade III)
- •10. Milde or severe renal failure (Creatinine Clearance = 80ml/min)
- •11. Unadjusted thyroid dysfunction
- •12. Acute gastric and intestinal ulcer
- •13. Other acute, serious illness of the subject
- •14. Subject is unable to understand the nature, scope, significance and consequences of this clinical trial.
- •15. Subject is unable to comply with the study design
- •16. Previous participation in this clinical trial or simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this clinical trial
- •Note to Exclusion Criterion 10. Mild or severe renal failure (Creatinine Clearance = 80ml/min):
- •If Creatinine Clearance at Screening Visit is > 80ml/min a 24 hour urin sample will be taken (collection start at day of Screening Visit) for re-assessment of Creatinine Clearance.
研究者
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