drugset / Trial / NCT07040137

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

NCT07040137 ↗

Phase 3 Recruiting 142 enrolled Kissei Pharmaceutical Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Subject rovatirelin Small molecule 2.4 mg Oral