NCT00640003已完成早期 1 期
Baclofen Treatment of Ataxia Telangiectasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Improvement in the decay constant for velocity storage as assessed by quantitative video examination of eye movement during and after rotation.
研究概览
简要总结
This research is being done to find out if Baclofen, a medicine that is often used for the treatment of abnormal stiffness, might also be useful to treat some of the neurologic problems caused by ataxia telangiectasia (A-T). The investigators also want to find out if there are better ways to measure the problems of ataxia and abnormal eye movement for future studies of medication in ataxia telangiectasia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Teenagers over 12 years old and young adults with A-T may join if they have been evaluated previously in the A-T Clinical Center at Johns Hopkins Hospital and have a measurable abnormality of eye movement.
- •Patients who are presently taking Baclofen will be eligible for the study if they are presently receiving the medication under the direction of Dr. Crawford in the ATCC, and are willing to withdraw from the medication for a period of one month prior to the initial screening visit.
- •Female patients who are sexually active will be given a standard serum HCG pregnancy test.
- •Those who are sexually active will be counseled about necessary precautions against pregnancy during the duration of the trial.
排除标准
- •A positive pregnancy test.
研究组 & 干预措施
1
Experimental
干预措施: Baclofen (Drug)
1
Experimental
干预措施: Placebo (Drug)
2
Experimental
干预措施: Baclofen (Drug)
2
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in the decay constant for velocity storage as assessed by quantitative video examination of eye movement during and after rotation.
时间窗: 3 months
次要结局
- Other outcome measures include quantitative measurement of tremor, postural stability and a standard neurologic examination.(3 months)
研究者
研究点 (1)
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