A Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Tolerability of Lithium in Multiple System Atrophy.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary Endpoint of the Study Will be the Difference in Number and Relative Frequency of Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) Recorded During the Study, Between Treatment and Placebo Group.
研究概览
简要总结
The purpose of this study is to determine safety and tolerability of the treatment with lithium in Multiple System Atrophy. Moreover, clinical symptoms, neuronal loss, quality of life and depressive symptoms, will be considered to further investigate the effect of lithium therapy.
详细描述
Patients will be progressively enrolled in the study and undergo a screening visit to test for inclusion/exclusion criteria. Patients will then be randomized to receive either Lithium carbonate or placebo. Patients will visit study center at 2, 4, 8, 12, 24, 36 and 48 weeks, for endpoint and laboratory assessments.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of probable MSA (Gilman, et al. 2008)
- •Age ≥18, <80
排除标准
- •Heart failure
- •Liver disease
- •Kidney failure
- •Thyroid disease
- •Sick sinus syndrome and/or significant ECG alterations
- •Hyposodemia
- •Treatment with diuretics
- •Treatment with haloperidol and/or other antipsychotics
- •Treatment with NSAIDs or corticosteroids
- •Treatment with ACE inhibitors
- •Treatment with aminophyllines
- •Treatment with mannitol
- •Pregnancy and/or breastfeeding
- •Acute diseases that might interfere with the trial
研究组 & 干预措施
Lithium CARBONATE 150 and/or 300 mg
干预措施: Lithium Carbonate (Drug)
Placebo
Placebo comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Endpoint of the Study Will be the Difference in Number and Relative Frequency of Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) Recorded During the Study, Between Treatment and Placebo Group.
时间窗: the endpoint will be recorded at all visits
Number of Adverse Events and their relative frequency in treatment groups was analyzed
次要结局
- The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.(48 weeks)
- Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.(48 weeks)
- Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.(48 weeks)
- Micro- and Macrostructural Magnetic Resonance Parameters Will be Compared Before and After Treatment. This Will Include Voxel Based Morphometry, Resting Functional MRI, Diffusion Tensor Imaging and MRI Spectroscopy.(48 weeks)
研究者
Alessandro Filla
Principal Investigator
Federico II University