SCD Clinical Trial
Official title:
A Randomized, Double Blind, Placebo-controlled Phase II Study of KPS-0373 in Patients With SCD
| NCT number | NCT01384435 |
| Other study ID # | KPS1203 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | June 23, 2011 |
| Last updated | November 29, 2012 |
The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Japanese SCD patients with mild to moderate ataxia Exclusion Criteria: - Patients with secondary ataxia - Patients with clinically significant hepatic, renal, or cardiovascular dysfunction |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Japan | Tokyo and Other Japanese City |
| Lead Sponsor | Collaborator |
|---|---|
| Kissei Pharmaceutical Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in Scale for the assessment and rating of ataxia (SARA) | 24 weeks | No | |
| Secondary | Change from baseline in patient improvement impression of activities of daily living | 24 weeks | No |
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