Spinocerebellar Degeneration Clinical Trial
NCT number | NCT01970124 |
Other study ID # | KPS1303 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | October 22, 2013 |
Last updated | April 15, 2016 |
The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Japanese SCD patients with ataxia Exclusion Criteria: - Patients with secondary ataxia - Patients with clinically significant hepatic, renal, or cardiovascular dysfunction |
N/A
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kissei Pharmaceutical Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SARA (Scale for the Assessment and Rating of Ataxia) | 52 weeks | No | |
Secondary | SF-8 (QOL) | 52 weeks | No |
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