A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Kissei Pharmaceutical Co., Ltd.200 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

SCD

Interventions

KPS-0373DRUG

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)

Japan

Tokyo and Other Japanese City, Japan

Outcomes

Primary Outcomes

Change from baseline in Scale for the assessment and rating of ataxia (SARA)

Time frame: 24 weeks

Secondary Outcomes

Change from baseline in patient improvement impression of activities of daily living

Time frame: 24 weeks

Data from ClinicalTrials.gov

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