RecruitingPhase 3

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

Japan142 participantsStarted 2025-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Japanese SCD patients with mild to moderate ataxia Exclusion Criteria: * Patients with secondary ataxia * Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

What they're measuring

Change from baseline in SARA total score at 24 weeks of treatment period

Timeframe: Up to 24 weeks

Trial details

NCT IDNCT07040137

SponsorKissei Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Kissei Pharmaceutical Co., Ltd Kissei Pharmaceutical Co., Ltd

Email only rinsyousiken@pharm.kissei.co.jp

View on ClinicalTrials.gov More Spinocerebellar Degeneration trials