Study Stopped
Data Monitoring Committee decision on 22nd August 2011 for safety issues
Lithium in Multiple System Atrophy
LAMU
A Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Tolerability of Lithium in Multiple System Atrophy.
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 16, 2009
CompletedFirst Posted
Study publicly available on registry
October 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
February 3, 2014
CompletedFebruary 3, 2014
December 1, 2013
1.8 years
October 16, 2009
March 6, 2013
December 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (11)
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.
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
- +6 more secondary outcomes
Study Arms (2)
Lithium CARBONATE 150 and/or 300 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORPlacebo comparator
Interventions
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of probable MSA (Gilman, et al. 2008)
- Age ≥18, \<80
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dipartimento di Scienze Neurologiche
Napoli, 80131, Italy
Related Publications (1)
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.
PMID: 18725592BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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
- Title
- Dr. Francesco Saccà
- Organization
- University Federico II, Naples, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandro Filla, MD
University Federico II
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 16, 2009
First Posted
October 19, 2009
Study Start
October 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
February 3, 2014
Results First Posted
February 3, 2014
Record last verified: 2013-12