Clinical trial NCT00997672: Lithium in Multiple System Atrophy
Official title: A Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Tolerability of Lithium in Multiple System Atrophy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple System Atrophy
Keywords: MSA
Lithium
Lithium carbonate
MSA-P
MSA-C
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Treatment with aminophyllines
* Treatment with mannitol
* Pregnancy and/or breastfeeding
* Acute diseases that might interfere with the trial

Primary outcomes:
measure: 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.
timeFrame: the endpoint will be recorded at all visits
Secondary outcomes:
measure: 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.
timeFrame: 0 weeks
measure: 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.
timeFrame: 0 weeks
measure: The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.
timeFrame: 0 weeks
measure: Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.
timeFrame: 0 weeks
measure: 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.
timeFrame: 24 weeks
measure: 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.
timeFrame: 48 weeks
measure: 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.
timeFrame: 48 weeks
measure: The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.
timeFrame: 24 weeks
measure: The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.
timeFrame: 48 weeks
measure: Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.
timeFrame: 24 weeks
measure: Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Dipartimento di Scienze Neurologiche
Study officials:
affiliation: University Federico II
name: Alessandro Filla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gilman S, Wenning GK, Low PA, Brooks DJ, Mathias CJ, Trojanowski JQ, Wood NW, Colosimo C, Durr A, Fowler CJ, Kaufmann H, Klockgether T, Lees A, Poewe W, Quinn N, Revesz T, Robertson D, Sandroni P, Seppi K, Vidailhet M. Second consensus statement on the diagnosis of multiple system atrophy. Neurology. 2008 Aug 26;71(9):670-6. doi: 10.1212/01.wnl.0000324625.00404.15.