Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Phase 2
Completed
- Conditions
- Spinocerebellar Degeneration
- Interventions
- Drug: KPS-0373
- Registration Number
- NCT00863538
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Brief Summary
To evaluate the efficacy, safety and pharmacokinetics profile of KPS-0373 in patients with SCD
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- SCD with mild to moderate ataxia
Read More
Exclusion Criteria
- Patients with secondary ataxia
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 KPS-0373 -
- Primary Outcome Measures
Name Time Method Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Japan
🇯🇵Kanto Region, Japan