Phase 3 Study of KPS-0373 Treatment in Adults with Spinocerebellar Degeneration

What this Trial Is About

Researchers are conducting a phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of KPS-0373 in patients with spinocerebellar degeneration. The study involves 142 patients with mild to moderate ataxia related to this condition. Participants will be followed through screening, treatment, and follow-up periods to assess treatment effects. The study includes three phases a 4-week screening period where all participants receive a placebo tablet once daily after breakfast a 24-week treatment period where patients are randomly assigned to receive either KPS-0373 2.4 mg or placebo once daily after breakfast and a 4-week follow-up period after treatment. Both study groups will take oral tablets daily, allowing comparison of KPS-0373 against placebo. Participants will undergo assessments including the Scale for the Assessment and Rating of Ataxia SARA to measure changes in ataxia symptoms at 24 weeks, along with other secondary measurements like quality of life questionnaires SF-8. Researchers will monitor safety and symptom changes throughout the study. The total duration of participation spans approximately 32 weeks from screening through follow-up.

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