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Lithium in Multiple System Atrophy (LAMU)

Primary Purpose

Multiple System Atrophy

Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Lithium Carbonate
Placebo
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple System Atrophy focused on measuring MSA, Lithium, Lithium carbonate, MSA-P, MSA-C

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dipartimento di Scienze Neurologiche

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lithium CARBONATE 150 and/or 300 mg

Placebo

Arm Description

Placebo comparator

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.
Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.
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.
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.
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.
The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.
The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.
Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.
Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.

Full Information

First Posted
October 16, 2009
Last Updated
December 17, 2013
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT00997672
Brief Title
Lithium in Multiple System Atrophy
Acronym
LAMU
Official Title
A Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Tolerability of Lithium in Multiple System Atrophy.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
Data Monitoring Committee decision on 22nd August 2011 for safety issues
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy
Keywords
MSA, Lithium, Lithium carbonate, MSA-P, MSA-C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lithium CARBONATE 150 and/or 300 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo comparator
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
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.
Description
Number of Adverse Events and their relative frequency in treatment groups was analyzed
Time Frame
the endpoint will be recorded at all visits
Secondary Outcome Measure Information:
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.
Time Frame
0 weeks
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.
Time Frame
0 weeks
Title
The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.
Time Frame
0 weeks
Title
Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.
Time Frame
0 weeks
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.
Time Frame
24 weeks
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.
Time Frame
48 weeks
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.
Time Frame
48 weeks
Title
The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.
Time Frame
24 weeks
Title
The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.
Time Frame
48 weeks
Title
Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.
Time Frame
24 weeks
Title
Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Filla, MD
Organizational Affiliation
University Federico II
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dipartimento di Scienze Neurologiche
City
Napoli
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18725592
Citation
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.
Results Reference
background
Links:
URL
http://www.unina.it
Description
University Federico II
URL
http://www.policlinico.unina.it
Description
AOU Policlinico "Federico II"

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Lithium in Multiple System Atrophy

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