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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00997672
Date of registration: 16/10/2009
Prospective Registration: No
Primary sponsor: Federico II University
Public title: Lithium in Multiple System Atrophy LAMU
Scientific title: A Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Tolerability of Lithium in Multiple System Atrophy.
Date of first enrolment: October 2009
Target sample size: 10
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT00997672
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
Italy
Contacts
Name:     Alessandro Filla, MD
Address: 
Telephone:
Email:
Affiliation:  University Federico II
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Multiple System Atrophy
Intervention(s)
Drug: Placebo
Drug: Lithium Carbonate
Primary Outcome(s)
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]
Secondary Outcome(s)
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]
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]
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]
Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale. [Time Frame: 24 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: 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: 0 weeks]
Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale. [Time Frame: 0 weeks]
The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory. [Time Frame: 48 weeks]
The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory. [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: 0 weeks]
Secondary ID(s)
Eudract n°2009-016377-15
MSA_LITIO_13
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 03/02/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00997672
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