EUCTR2013-000107-17-DE进行中（未招募）1 期
Pharmacological therapy of episodic ataxia type 2: a placebo-controlled comparison of the efficacy of 4-aminopyridine sustained-release (Fampyra TM) and acetazolamide (Acemit TM) - 4-aminopyridine sustained-release (Fampyra TM) and acetazolamide (Acemit TM) in patients with EA2
Hospital of the University of Munich, Grosshadern0 个研究点开始时间: 2013年4月5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 randomized in the study if they meet all of the following criteria:
- •1. Written informed consent of the subject
- •2. Patients (male or female) aged 18 years or older
- •3. Genetically confirmed episodic ataxia type 2 or a familial history of ataxia with clinical picture of episodic ataxia type 2 starting in childhood
- •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 randomized 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. Known hypersensitivity to aminopyridine and/or acetazolamide/sulfonamide
- •5. 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), severe arterial hypertension (grade III according to the guidelines of the German society of cardiology, 2008)
- •6. Recently occurred stroke (within the last 3 months)
- •7. Epileptic seizure currently or in the past
- •8. Asthma (severity = grade III)
- •9. Obstructive lung disease (e.g. pulmonary emphysema)
- •10. Liver insufficiency defined as GOT/GPT/total bilirubin > 3 x upper range
- •(e.g. cirrhosis of the liver)
- •11. Milde or severe renal failure (Creatinine Clearance = 80ml/min)
- •12. Addison's disease
- •13. Unadjusted thyroid dysfunction
- •14. Acute gastric and intestinal ulcer
- •15. Known hyperchloremic acidosis
- •16. Depressed sodium and/or potassium blood serum levels
- •17. Chronic noncongestive glaucoma
- •18. Hypercalcaemia
- •19. Articular gout
- •20. Known African anaemia
- •21. Diabetes mellitus type I/II
- •22. Other acute, serious illness of the subject
- •23. Subject is unable to understand the scope, significance and consequences of this clinical trial and is unable to comply with the study design
- •24. Previous participation in this clinical trial or participation in any clinical trial taking an investigational medicinal product within 30 days prior to written informed consent for this clinical trial
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