NCT00998634

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

Randomized, Placebo-controlled Trial to Test Safety, Tolerability and Efficacy of Lithium Carbonate in Spinocerebellar Ataxia 2

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• SPINOCEREBELLAR ATAXIA 2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2009-10-20
• Last updated: 2013-01-08

Locations

1 site across 1 country: Italy