EUCTR2012-003315-63-ES进行中（未招募）1 期
RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, STUDY OF EFFECTIVENESS, TOLERABILITY AND SAFETY OF THERAPY WITH AMANTADINE IN DEGENERATIVE ATAXIAS
FIBHULP0 个研究点目标入组 150 人开始时间: 2012年8月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •- Age equal or greater than 18 and less than 85 years
- •- Patients with degenerative ataxias with scores between 8 and 34 points on the SARA scale
- •- Patients with and without cardiomyopathy
- •- Can be included patients stably treated with idebenone and / or riboflavin and / or deferiprone or darbepoetin for at least 1 year
- •- Having given informed consent
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Age under 18 or over 85 years
- •- SARA Scale score <8 and> 34 points
- •- Impared to proximal level muscle strength of lower extremity in a grade ? 4 points in the Gradual Neurological Scale
- •- Sensory function (primary modes + estereognosia) altered at a rate of ? 9 Gradual Neurological Scale
- •- Significant neurological disease that may affect cognition: dementia, Down syndrome
- •- Current presence of disorder or clinically significant psychiatric symptoms (eg hallucinations), according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), which may affect the patient's ability to complete the study.
研究者
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