Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07040137

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

Led by Kissei Pharmaceutical Co., Ltd. · Updated on 2025-06-27

142

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Japanese patients diagnosed with spinocerebellar degeneration
  • Patients with mild to moderate ataxia
Not Eligible

You will not qualify if you...

  • Patients with secondary ataxia
  • Patients with clinically significant liver, kidney, or heart problems

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Research Site

Multiple Locations, Japan

Actively Recruiting

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Research Team

K

Kissei Pharmaceutical Co., Ltd Kissei Pharmaceutical Co., Ltd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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