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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract n°2009-016377-15 |
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Data Monitoring Committee decision on 22nd August 2011 for safety issues
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium CARBONATE 150 and/or 300 mg | Experimental |
| |
| Placebo | Placebo Comparator | Placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium Carbonate | Drug | Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Number of Adverse Events and their relative frequency in treatment groups was analyzed | the endpoint will be recorded at all visits |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro Filla, MD | University Federico II | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento di Scienze Neurologiche | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18725592 | Background | 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. |
| Label | URL |
|---|---|
| University Federico II | View source |
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Patients were screened prior to randomization, no patients were excluded.
Patients were recruited through our outpatient clinic. Recruitment started the 4th June 2010 and the trial was stopped the 22nd of August 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Lithium CARBONATE 150 or 300 mg | Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day. |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lithium CARBONATE 150 or 300 mg | Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of Adverse Events and their relative frequency in treatment groups was analyzed | Posted | Number | number of AEs | the endpoint will be recorded at all visits |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lithium CARBONATE 150 or 300 mg | Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | MedDRA (10.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower limbs weakness | Nervous system disorders | Systematic Assessment |
Limitation of the study is small sample size of nine randomized patients. This may have determined uneven distribution of AEs due to random variation. Taking into account these limitations, we do not encourage future studies with lithium in MSA.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francesco Saccà | University Federico II, Naples, Italy | 3470734774 | +39 | francesco.sacca@unina.it |
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| ID | Term |
|---|---|
| D019578 | Multiple System Atrophy |
| ID | Term |
|---|---|
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001480 | Basal Ganglia Diseases |
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| ID | Term |
|---|---|
| D016651 | Lithium Carbonate |
| ID | Term |
|---|---|
| D002254 | Carbonates |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D002255 | Carbonic Acid |
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| Placebo | Drug |
|
| 0 weeks |
| The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory. | 0 weeks |
| Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale. | 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. | 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. | 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 |
| The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory. | 24 weeks |
| 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. | 24 weeks |
| Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale. | 48 weeks |
| AOU Policlinico "Federico II" | View source |
Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Not Posted | 0 weeks |
| Secondary | 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. | Not Posted | 0 weeks |
| Secondary | The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory. | Not Posted | 0 weeks |
| Secondary | Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale. | Not Posted | 0 weeks |
| Secondary | 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. | Not Posted | 24 weeks |
| Secondary | 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. | Not Posted | 48 weeks |
| Secondary | 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. | Not Posted | 48 weeks |
| Secondary | The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory. | Not Posted | 24 weeks |
| Secondary | The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory. | Not Posted | 48 weeks |
| Secondary | Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale. | Not Posted | 24 weeks |
| Secondary | Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale. | Not Posted | 48 weeks |
| 4 |
| 4 |
| 4 |
| 4 |
| EG001 | Placebo | Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day. | 1 | 5 | 3 | 5 |
| Cardiovascular failure | Cardiac disorders |
|
| Pulmonary infection | Respiratory, thoracic and mediastinal disorders |
|
| Fever | Infections and infestations |
|
| Inguinal abscess | Infections and infestations |
|
| sleepiness | Nervous system disorders | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | Systematic Assessment |
|
| Cystitis | Renal and urinary disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| joint rigidity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| pulmonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| gastroaesophageal reflux | Gastrointestinal disorders | Systematic Assessment |
|
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| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D017554 |
| Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |