A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Phase 3CompletedNCT01970098

Kissei Pharmaceutical Co., Ltd.374 enrolled

Overview

The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

374

Conditions

Spinocerebellar Degeneration

Interventions

KPS-0373, High doseDRUG

28 weeks

KPS-0373, Low doseDRUG

28 weeks

PlaceboDRUG

28 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Multiple Locations, Japan

Outcomes

Primary Outcomes

SARA (Scale for the Assessment and Rating of Ataxia)

The change in the SARA total score at the time of final evaluation

Time frame: 24 weeks

Secondary Outcomes

SF-8 (QOL)

Time frame: 24 weeks

Data from ClinicalTrials.gov

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