Lithium in Multiple System Atrophy (LAMU)

This study has been terminated.
(Data Monitoring Committee decision on 22nd August 2011 for safety issues)
Sponsor:
Information provided by (Responsible Party):
Alessandro Filla, Federico II University
ClinicalTrials.gov Identifier:
NCT00997672
First received: October 16, 2009
Last updated: December 17, 2013
Last verified: December 2013
Results First Received: March 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Multiple System Atrophy
Interventions: Drug: Lithium Carbonate
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened prior to randomization, no patients were excluded.

Reporting Groups
  Description
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.
Placebo Placebo

Participant Flow:   Overall Study
    Lithium CARBONATE 150 or 300 mg     Placebo  
STARTED     4     5  
COMPLETED     0     1  
NOT COMPLETED     4     4  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Lithium CARBONATE 150 or 300 mg     Placebo     Total  
Number of Participants  
[units: participants]
  4     5     9  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     4     6  
>=65 years     2     1     3  
Age  
[units: years]
Mean ± Standard Deviation
  65  ± 5     64  ± 6     64  ± 5  
Gender  
[units: participants]
     
Female     2     0     2  
Male     2     5     7  
Region of Enrollment  
[units: participants]
     
Italy     4     5     9  



  Outcome Measures

1.  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.   [ Time Frame: the endpoint will be recorded at all visits ]

2.  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.   [ Time Frame: 0 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  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.   [ Time Frame: 0 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.   [ Time Frame: 0 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.   [ Time Frame: 0 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  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.   [ Time Frame: 24 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  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.   [ Time Frame: 48 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  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.   [ Time Frame: 48 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.   [ Time Frame: 24 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.   [ Time Frame: 48 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.   [ Time Frame: 24 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.   [ Time Frame: 48 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: Dr. Francesco Saccà
Organization: University Federico II, Naples, Italy
phone: 3470734774 ext +39
e-mail: francesco.sacca@unina.it


Publications:

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
Study First Received: October 16, 2009
Results First Received: March 6, 2013
Last Updated: December 17, 2013
Health Authority: Italy: Ethics Committee