Spinocerebellar Degeneration Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Crossover Study, Followed by Open-label Study of KPS-0373 in Patients With SCD
NCT number | NCT01004016 |
Other study ID # | KPS1202 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | October 27, 2009 |
Last updated | September 27, 2010 |
To evaluate the efficacy and safety of KPS-0373 in patients with SCD.
Status | Completed |
Enrollment | 20 |
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: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Japan | Japan |
Lead Sponsor | Collaborator |
---|---|
Kissei Pharmaceutical Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Scale for Assessment and Rating of Ataxia (SARA) | 4 weeks + 12 weeks | No | |
Primary | Upper and lower extremity function | 4 weeks + 12 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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