An Extension Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Phase 3CompletedNCT01970111

Kissei Pharmaceutical Co., Ltd.

Overview

The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients.

Study Type

INTERVENTIONAL

Conditions

Spinocerebellar Degeneration

Interventions

KPS-0373, High doseDRUG

KPS-0373, Low doseDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Japanese SCD patients with mild to moderate ataxia (Completion of the KPS1301 study) Exclusion Criteria: * Less than 75% of compliance in KPS1301 study

Locations (1)

Unnamed facility

Tokyo and Other Japanese Cities, Japan

Outcomes

Primary Outcomes

SARA (Scale for the Assessment and Rating of Ataxia)

Time frame: 52 weeks

Secondary Outcomes

SF-8 (QOL)

Time frame: 52 weeks

Data from ClinicalTrials.gov

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