Efficacy and Safety pf Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries: a Double-Blind, Randomized, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes of Neurological Scores for Baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Placebo tablet
干预措施: Placebo (Drug)
Lithium carbonate
Lithium Carbonate tablet, 250mg
干预措施: Lithium Carbonate (Drug)
结局指标
主要结局
Changes of Neurological Scores for Baseline
时间窗: 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.
次要结局
- Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain(6 months)