A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Phase 3CompletedNCT01970137

Kissei Pharmaceutical Co., Ltd.

Overview

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)

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 ataxia (Experience of clinical trials of KPS-0373) Exclusion Criteria: * Patients with secondary ataxia * Patients with clinically significant hepatic, renal, or cardiovascular dysfunction * Discontinuations in another clinical trials caused by side effects

Locations (1)

Unnamed facility

Tokyo and Other Japanese Cities, Japan

Outcomes

Primary Outcomes

SARA (Scale for the Assessment and Rating of Ataxia)

Time frame: 24 weeks

Secondary Outcomes

SF-8 (QOL)

Time frame: 24 weeks

Data from ClinicalTrials.gov

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