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Trial record 10 of 91 for:    "Brain Diseases" AND "Multiple System Atrophy"

Lithium in Multiple System Atrophy (LAMU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00997672
Recruitment Status : Terminated (Data Monitoring Committee decision on 22nd August 2011 for safety issues)
First Posted : October 19, 2009
Results First Posted : February 3, 2014
Last Update Posted : February 3, 2014
Sponsor:
Information provided by (Responsible Party):
Alessandro Filla, Federico II University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple System Atrophy
Interventions Drug: Lithium Carbonate
Drug: Placebo
Enrollment 10
Recruitment Details Patients were recruited through our outpatient clinic. Recruitment started the 4th June 2010 and the trial was stopped the 22nd of August 2011
Pre-assignment Details Patients were screened prior to randomization, no patients were excluded.
Arm/Group Title Lithium CARBONATE 150 or 300 mg Placebo
Hide Arm/Group Description 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. Placebo
Period Title: Overall Study
Started 4 5
Completed 0 1
Not Completed 4 4
Arm/Group Title Lithium CARBONATE 150 or 300 mg Placebo Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  50.0%
4
  80.0%
6
  66.7%
>=65 years
2
  50.0%
1
  20.0%
3
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 9 participants
65  (5) 64  (6) 64  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female
2
  50.0%
0
   0.0%
2
  22.2%
Male
2
  50.0%
5
 100.0%
7
  77.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 4 participants 5 participants 9 participants
4 5 9
1.Primary Outcome
Title 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.
Hide Description Number of Adverse Events and their relative frequency in treatment groups was analyzed
Time Frame the endpoint will be recorded at all visits
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lithium CARBONATE 150 or 300 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 4 5
Measure Type: Number
Unit of Measure: number of AEs
58 21
2.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 0 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 0 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.
Hide Description [Not Specified]
Time Frame 0 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.
Hide Description [Not Specified]
Time Frame 0 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 24 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 48 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 48 weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.
Hide Description [Not Specified]
Time Frame 24 weeks
Outcome Measure Data Not Reported
10.Secondary Outcome
Title The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.
Hide Description [Not Specified]
Time Frame 48 weeks
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.
Hide Description [Not Specified]
Time Frame 24 weeks
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.
Hide Description [Not Specified]
Time Frame 48 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lithium CARBONATE 150 or 300 mg Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Lithium CARBONATE 150 or 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lithium CARBONATE 150 or 300 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      1/5 (20.00%)    
Cardiac disorders     
Death  1/4 (25.00%)  1 1/5 (20.00%)  1
Cardiovascular failure  1/4 (25.00%)  1 1/5 (20.00%)  1
Infections and infestations     
Fever  1/4 (25.00%)  1 0/5 (0.00%)  0
Inguinal abscess  1/4 (25.00%)  1 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary infection  0/4 (0.00%)  0 1/5 (20.00%)  1
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lithium CARBONATE 150 or 300 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      3/5 (60.00%)    
Gastrointestinal disorders     
diarrhea   2/4 (50.00%)  4 2/5 (40.00%)  5
gastroaesophageal reflux   1/4 (25.00%)  4 2/5 (40.00%)  5
Musculoskeletal and connective tissue disorders     
joint rigidity   2/4 (50.00%)  4 1/5 (20.00%)  5
Nervous system disorders     
Lower limbs weakness   3/4 (75.00%)  4 3/5 (60.00%)  5
sleepiness   1/4 (25.00%)  4 2/5 (40.00%)  5
Renal and urinary disorders     
Incontinence   1/4 (25.00%)  4 3/5 (60.00%)  5
Cystitis   2/4 (50.00%)  4 1/5 (20.00%)  5
Respiratory, thoracic and mediastinal disorders     
pulmonitis   1/4 (25.00%)  4 1/5 (20.00%)  5
Indicates events were collected by 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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Francesco Saccà
Organization: University Federico II, Naples, Italy
Phone: 3470734774 ext +39
EMail: francesco.sacca@unina.it
Layout table for additonal information
Responsible Party: Alessandro Filla, Federico II University
ClinicalTrials.gov Identifier: NCT00997672     History of Changes
Other Study ID Numbers: MSA_LITIO_13
Eudract n°2009−016377−15
First Submitted: October 16, 2009
First Posted: October 19, 2009
Results First Submitted: March 6, 2013
Results First Posted: February 3, 2014
Last Update Posted: February 3, 2014