drugset / Trial / NCT07040137
Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-07
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rovatirelin | Small molecule | 2.4 mg | Oral |