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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