Clinical Trial: Lithium in Multiple System Atrophy

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Tolerability of Lithium in Multiple System Atrophy.

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 Summary: 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.
Sponsor: Federico II University

Current Primary Outcome: 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


Original Primary Outcome: Primary endpoint of the study will be the difference in Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) recorded during the study, between treatment and placebo group. [ Time Frame: all visits ]

Current Secondary Outcome:

  • 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. [ Time Frame: 0 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. [ Time Frame: 0 weeks ]
  • The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory. [ Time Frame: 0 weeks ]
  • Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale. [ Time Frame: 0 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. [ Time Frame: 24 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. [ Time Frame: 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. [ Time Frame: 48 weeks ]
  • The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory. [ Time Frame: 24 weeks ]
  • The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory. [ Time Frame: 48 weeks ]
  • Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale. [ Time Frame: 24 weeks ]
  • Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale. [ Time Frame: 48 weeks ]


Original Secondary Outcome: Same as current

Information By: Federico II University

Dates:
Date Received: October 16, 2009
Date Started: October 2009
Date Completion:
Last Updated: December 17, 2013
Last Verified: December 2013