A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Phase 3
Completed
- Conditions
- Spinocerebellar Degeneration
- Interventions
- Drug: KPS-0373, High doseDrug: KPS-0373, Low dose
- Registration Number
- NCT01970137
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Japanese SCD patients with ataxia (Experience of clinical trials of KPS-0373)
Exclusion Criteria
- Patients with secondary ataxia
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
- Discontinuations in another clinical trials caused by side effects
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description KPS-0373 KPS-0373, Low dose - KPS-0373 KPS-0373, High dose -
- Primary Outcome Measures
Name Time Method SARA (Scale for the Assessment and Rating of Ataxia) 24 weeks
- Secondary Outcome Measures
Name Time Method SF-8 (QOL) 24 weeks