EUCTR2008-001185-91-IT进行中（未招募）不适用
Central randomized, double-blind, crossover, multicenter clinical trial of Betametasone and placebo in children with ataxia teleangectasia - FMPS?30094
AZIENDA OSPEDALIERA SENESE0 个研究点开始时间: 2008年5月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •INCLUSION CRITERIA 1) proven molecular diagnosis of A-T (AFP level more than twice the upper limit of normal and demonstration of ATM protein deficiency by Western blot); 2) evident neurological signs of ataxia (uncoordination of head and eyes in lateral gaze deflection, gait ataxia associated with an inappropriately narrow base); 3) age between 3; 4) plasma CD4+ lymphocytes/mm3 >= 500 (3-6 years) or >= 200 (> 6 years); 5) written informed consent to participate from the parents and verbal consent to participate from the patient, if able to understand the main concepts and aims of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) confinement to a wheelchair (i.e. inability to walk),
- •2) current or previous neoplastic disease,
- •3) history of severe impairment of the immunological system (i.e. history of serious infectious disease),
- •4) presence of other chronic conditions (i.e. diabetes, mental delay, osteoporosis, etc) representing a contraindication to the use of a steroid drug
- •5) noncompliance with the aims and methods of the study.
研究者
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