Lithium in Multiple System Atrophy

Multiple System Atrophy Clinical Trial

— LAMU  

Official title:

A Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Tolerability of Lithium in Multiple System Atrophy.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00997672
• Other study ID #: MSA_LITIO_13
• Secondary ID: Eudract n°2009-0
• Status: Terminated
• Phase: Phase 2
• First received: October 16, 2009
• Last updated: December 17, 2013
• Start date: October 2009
• Est. completion date: August 2011

Study information

• Verified date: December 2013
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Shy-Drager Syndrome

Intervention

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.
• Placebo

Locations

Country	Name	City	State
Italy	Dipartimento di Scienze Neurologiche	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Number of Adverse Events and their relative frequency in treatment groups was analyzed	the endpoint will be recorded at all visits	Yes
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.		0 weeks	No
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.		0 weeks	No
Secondary	The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.		0 weeks	No
Secondary	Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.		0 weeks	No
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.		24 weeks	No
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.		48 weeks	No
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.		48 weeks	No
Secondary	The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.		24 weeks	No
Secondary	The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.		48 weeks	No
Secondary	Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.		24 weeks	No
Secondary	Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.		48 weeks	No

External Links

•   AISA sez. Campania
•   AOU Policlinico "Federico II"
•   University Federico II