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Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration
Sponsor: Kissei Pharmaceutical Co., Ltd.
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.
Official title: Phase III Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2025-07
Completion Date
2027-03-31
Last Updated
2025-06-27
Healthy Volunteers
No
Conditions
Interventions
KPS-0373
Oral administration
Placebo
Oral administration
Locations (1)
Research Site
Multiple Locations, Japan