KPS-0373 for people with spinocerebellar degeneration
Phase III Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration
This study will test whether taking KPS-0373 once daily after breakfast helps Japanese adults with mild to moderate spinocerebellar degeneration over 24 weeks compared with a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kissei Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT07040137 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III trial enrolling 142 patients with mild to moderate spinocerebellar degeneration. After a 4-week screening period, participants will be randomized to receive KPS-0373 or matching placebo once daily after breakfast for 24 weeks, followed by a 4-week follow-up. The trial will monitor clinical measures of ataxia and safety outcomes, excluding patients with secondary ataxia or significant hepatic, renal, or cardiovascular dysfunction. The design aims to confirm earlier-phase findings on efficacy and tolerability in a larger, controlled population.
Who should consider this trial
Good fit: Ideal candidates are Japanese adults with primary spinocerebellar degeneration who have mild to moderate ataxia and do not have significant liver, kidney, or heart disease.
Not a fit: Patients with secondary causes of ataxia, severe disease, or clinically significant hepatic, renal, or cardiovascular dysfunction are unlikely to qualify or benefit from this treatment.
Why it matters
Potential benefit: If successful, KPS-0373 could reduce symptoms of ataxia and improve daily functioning for people with spinocerebellar degeneration.
How similar studies have performed: Earlier-phase clinical work with KPS-0373 provided sufficient signals of safety and potential efficacy to support this confirmatory phase III, but the approach remains investigational until confirmed.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Multiple Locations
- Research Site — Multiple Locations, Japan (Recruiting)
Study contacts
- Study coordinator: Kissei Pharmaceutical Co., Ltd Kissei Pharmaceutical Co., Ltd
- Email: rinsyousiken@pharm.kissei.co.jp
- Phone: Email only
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.