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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Spinocerebellar Degeneration

In brief

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.

Key facts

Study ID

NCT07040137

Run by

Kissei Pharmaceutical Co., Ltd.

People needed

142

Starts

2025-07-01

Expected to finish

2027-03-31

Last updated by the study team

2025-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Japanese SCD patients with mild to moderate ataxia

You may not qualify if…

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

Where it is running

• Research Site — Multiple Locations, Japan (enrolling)

Full record on ClinicalTrials.gov

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