A Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Tolerability of Lithium in Multiple System Atrophy.
Overview
- Phase
- Phase 2
- Intervention
- Lithium Carbonate
- Conditions
- Multiple System Atrophy
- Sponsor
- Federico II University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Alessandro Filla
Principal Investigator
Federico II University
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of probable MSA (Gilman, et al. 2008)
- •Age ≥18, \<80
Exclusion Criteria
- •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
Arms & Interventions
Lithium CARBONATE 150 and/or 300 mg
Intervention: Lithium Carbonate
Placebo
Placebo comparator
Intervention: Placebo
Outcomes
Primary Outcomes
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.
Time Frame: the endpoint will be recorded at all visits
Number of Adverse Events and their relative frequency in treatment groups was analyzed
Secondary Outcomes
- 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)