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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

Tracking Information
First Submitted Date  ICMJE October 16, 2009
First Posted Date  ICMJE October 19, 2009
Results First Submitted Date  ICMJE March 6, 2013
Results First Posted Date  ICMJE February 3, 2014
Last Update Posted Date February 3, 2014
Study Start Date  ICMJE October 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2013)
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 ]
Number of Adverse Events and their relative frequency in treatment groups was analyzed
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2009)
Primary endpoint of the study will be the difference in Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) recorded during the study, between treatment and placebo group. [ Time Frame: all visits ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2009)
  • 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 ]
  • 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 ]
  • 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: 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. [ 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: 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: 48 weeks ]
  • The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory. [ Time Frame: 24 weeks ]
  • The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory. [ Time Frame: 48 weeks ]
  • Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale. [ Time Frame: 24 weeks ]
  • Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale. [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lithium in Multiple System Atrophy
Official Title  ICMJE A Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Tolerability of Lithium in Multiple System Atrophy.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple System Atrophy
Intervention  ICMJE
  • Drug: 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.
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Lithium CARBONATE 150 and/or 300 mg
    Intervention: Drug: Lithium Carbonate
  • Placebo Comparator: Placebo
    Placebo comparator
    Intervention: Drug: Placebo
Publications * Gilman S, Wenning GK, Low PA, Brooks DJ, Mathias CJ, Trojanowski JQ, Wood NW, Colosimo C, Dürr 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 19, 2011)
10
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2009)
40
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00997672
Other Study ID Numbers  ICMJE MSA_LITIO_13
Eudract n°2009-016377-15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alessandro Filla, Federico II University
Study Sponsor  ICMJE Federico II University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alessandro Filla, MD University Federico II
PRS Account Federico II University
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP