NCT07040137

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Kissei Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinocerebellar Degeneration

Interventions

Type	Name	Description
DRUG	KPS-0373	Oral administration
DRUG	Placebo	Oral administration

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

1 site across 1 country: Japan