RecruitingPhase 3NCT07040137

Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration

Phase III Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration

Sponsor

Kissei Pharmaceutical Co., Ltd.

Enrollment

142 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Spinocerebellar Degeneration

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase III study to evaluate the efficacy and safety of KPS-0373 given once daily after breakfast in 142 patients with spinocerebellar degeneration . This study consists of the 4-week screening period, 24-week treatment period, and 4-week follow-up period.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

Japanese SCD patients with mild to moderate ataxia

Exclusion Criteria2

Patients with secondary ataxia
Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

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Interventions

DRUGKPS-0373

Oral administration

DRUGPlacebo

Oral administration

Locations(1)

Research Site

Multiple Locations, Japan

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NCT07040137