Double Blind, Randomized Placebo-controlled Clinical Study Evaluating the Efficacy of Lithium Carbonate in the Treatment of Neuropathic Pain of Patients With Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks
研究概览
简要总结
To investigate the efficacy of lithium carbonate in the treatment of neuropathic pain of patients with spinal cord injury.
详细描述
This is a randomized, placebo-controlled, double-blinded trial. Sixty spinal cord injured subjects with neuropathic pain will be randomized into two groups. The subject in the Treatment Group will receive lithium carbonate tablet, while the Control Group will receive placebo tablet. Neither the subjects nor the physicians know which group the subjects are allocated.
Each subject will receive 6 weeks of oral lithium carbonate or placebo. In the Treatment Group, the dose will be adjusted according to the serum lithium level. While in the Control Group, the dose will be adjusted based on the dummy serum level report.
The outcome will be assessed during visits at 1 week, 2 weeks, 6 weeks and 12 weeks, and a phone call follow-up at 24 weeks from the start of the medication. The primary outcome measure is the severity level of pain. The efficacy and safety will be analyzed by 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 65;
- •Diagnosis of traumatic spinal cord injury;
- •Clinically diagnosed neuropathic pain;
- •Pain severity is at least 4 on a 11-point numeric rating scale at screening;
- •Pain present regularly for at least 6 weeks before enrollment;
- •Able to understand instructions and provide reliable pain assessments;
- •Subjects who are voluntarily signed and dated an Ethics Committee approved informed consent form;
排除标准
- •Significant renal, cardiovascular, hepatic, infectious or psychiatric disease;
- •Significant brain injury with neurological deficits;
- •Debilitation or dehydration;
- •Addison's disease;
- •Recent (within 1 week) or current use of anti-diuretics or other drugs that interacts with lithium, such as tricyclic antidepressants, nonsteroidal antiinflammatory drug and tetracyclines;
- •A history of substance or alcohol abuse within past 1 year;
- •A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period;
- •Current pregnant or breast feeding, or female who has childbearing potential but is not willing to use an approved method of birth control;
- •Participation in any drug study in the last three months;
- •History of oral lithium intake for any reason; or
- •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
Lithium treatment group
Lithium carbonate, 250mg/tablet. The dose starts with three times a day and one tablet each time for a week. The daily dose will then be adjusted according to serum lithium level and clinical finding. Target serum lithium level is 0.6 - 1.2mmol/L.
干预措施: Lithium Carbonate (Drug)
Control group
The dose of the placebo will be adjusted according to the dummy serum level report.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks
时间窗: D0, Wk 1, 2, 6, 12, and 24
pain severity level
次要结局
- Change in Short-Form 36 single question(D0, Wk 1, 2, 6, 12, and 24)
- Change in Multidimensional Pain Inventory Life Interference Subscale (MPI-LIS)(D0, Wk 1, 2, 6, 12 and 24)
- Change in Sleep Interference Assessment score(D0, Wk 1, 2, 6, 12 and 24)
- Change in weekly number of days with pain attack(D0, Wk 1, 2, 6, 12 and 24)
- Change in the Patient Global Impression of Change (PGIC)(Wk 1, 2, 6, and 12)
- Change in Patient Health Questionnaire (PHQ-9)(D0, Wk 1, 2, 6 and 12)
- Change in sensory score, motor score and ASIA impairment (AIS) scale(D0, Wk 6 and 12)
- Change in Modified Ashworth Scale(D0, Wk 6 and 12)
- Magnetic resonance diffusion tensor imaging (optional)(D0, Wk 6 and 12)
- Electrophysiology (optional)(D0, Wk 6 and 12)