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Safety and Tolerability of Lithium in Spinocerebellar Ataxia 2 (SCA2)

2014-08-27 03:18:33 | BioPortfolio

Summary

The purpose of this study is to determine safety and tolerability of the treatment with lithium in Spinocerebellar Ataxia 2. 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.

Study Design

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

Conditions

Spinocerebellar Ataxia 2

Intervention

LITHIUM CARBONATE

Location

Dipartimento di Scienze Neurologiche
Napoli
Italy
80131

Status

Recruiting

Source

Federico II University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:33-0400

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Medical and Biotech [MESH] Definitions

A lithium salt, classified as a mood-stabilizing agent. Lithium ion alters the metabolism of BIOGENIC MONOAMINES in the CENTRAL NERVOUS SYSTEM, and affects multiple neurotransmission systems.

A salt of lithium that has been used experimentally as an immunomodulator.

Inorganic compounds that contain lithium as an integral part of the molecule.

An ataxin that is associated with the survival of cerebellar neurons. Expansion of the ATTCT pentanucleotide in the ATXN10 coding region is associated with SPINOCEREBELLAR ATAXIA 10.

An element in the alkali metals family. It has the atomic symbol Li, atomic number 3, and atomic weight 6.94. Salts of lithium are used in treating BIPOLAR DISORDER.

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