Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries
Efficacy and Safety pf Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries: a Double-Blind, Randomized, Placebo-Controlled Clinical Trial
This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be randomized into two groups. The subjects in the Treatment Group will be administered with lithium carbonate, while the Control Group will receive placebo.
Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment group, the dose will be adjusted according to the serum lithium level while in the control group there will be a sham adjustment.
The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The outcomes will be compared with baseline pre-treatment data to obtain "neurological change scores." The efficacy and safety will be analyzed comparing the results of the treatment group with those of the control group.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subjects of either gender and 18-60 years of age;
- Subjects with chromic spinal cord injury (defined as a history of spinal cord injury for 12 months or longer);
- Subjects with ASIA - classification of A, B, or C for at least 6 months unchanged;
- Spinal cord injury vertebral level should be between C4 and T10;
- Subjects must be able to read, understand, and complete the VAS;
- Subjects who have voluntarily signed and dated an informed consent form, approved by an IRB/IEC, prior to any study specific procedures.
Exclusion Criteria:
- A history of hypersensitivity or other adverse reaction to lithium;
- Significant renal, cardiovascular, hepatic and psychiatric disease;
- Significant medical diseases or infection;
- Addison's disease;
- Debilitation or dehydration;
- Recently taken or are taking diuretics or other drugs with known interaction with lithium, such as tricyclic antidepressants, NSAIDs and tetracyclines;
- A history of alcohol abuse or drug abuse;
- Pregnant or lactating women;
- Female of childbearing potential and are unwilling to use an effective contraceptive method while enrolled in the study;
- Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study;
- Subjects who have taken lithium for manic depression or other psychiatric conditions,and finally;
- Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:安慰剂
安慰剂片剂
|
匹配安慰剂
|
实验性的:Lithium carbonate
Lithium Carbonate tablet, 250mg
|
The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM. The course of medication is 6 weeks. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Changes of Neurological Scores for Baseline
大体时间:6 months
|
Changes of Motor Scores (0 ~ 100), Pin Prick Scores (0 ~ 112) and Light Touch Scores (0 ~ 112) from Baseline to Week 6 and Month 6.
The higher the changes the better the functional improvement.
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain
大体时间:6 months
|
Changes from Baseline to Week 6 and Month 6 in Functional Independence Measure (FIM) motor subscale (0 ~ 91, the higher the better), Visual Analog Scale (VAS) for pain (0 ~ 100, the less the better)
|
6 months
|
合作者和调查者
调查人员
- 首席研究员:Mingliang Yang, MD, Ph.D、China Rehabilitation and Research Center
- 首席研究员:Tzu-Yung Chen, MD、Buddhist Tzu Chi General Hospita, Taichung Branch
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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