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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federico II University
• Treatments: Lithium Carbonate

Criteria

Inclusion Criteria:

• Molecular diagnosis of SCA2 (≥34 CAG in the ataxin-2 gene)

• Age ≥18, <80

• SARA score ≥8

Exclusion Criteria:

• 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