Status:
COMPLETED
Safety and Tolerability of Lithium in Spinocerebellar Ataxia 2 (SCA2)
Lead Sponsor:
Federico II University
Conditions:
SPINOCEREBELLAR ATAXIA 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ...
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 pla...
Eligibility Criteria
Inclusion
- Molecular diagnosis of SCA2 (≥34 CAG in the ataxin-2 gene)
- Age ≥18, \<80
- SARA score ≥8
Exclusion
- SARA score \>32
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00998634
Start Date
October 1 2009
End Date
November 1 2012
Last Update
January 8 2013
Active Locations (1)
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1
Dipartimento di Scienze Neurologiche
Napoli, Italy, 80131