Confirmatory study 3 of KPS-0373 in patients with spinocerebellar degeneration

Phase III confirmatory study 3 of KPS-0373 in patients with spinocerebellar degeneration

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011250017

Enrollment

142

Registered

2025-06-25

Start date

2025-07-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinocerebellar Degeneration

Interventions

The investigational product (KPS-0373 2.4 mg tablet or placebo tablet) is orally administered once daily after breakfast.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Japanese spinocerebellar degeneration patients with mild to moderate ataxia

Exclusion criteria

Exclusion criteria: 1)Patients with secondary ataxia 2)Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Design outcomes

Primary

Measure	Time frame
The change from baseline in total SARA score at Week 24 of the treatment period	—

Secondary

Measure	Time frame
- The change from baseline in total SARA score - Proportion of subjects maintaining symptoms based on the total SARA score (proportion of subjects with improvement and subjects with no change) - The changes from baseline in individual SARA scores - The change from baseline in SF-8 - Incidence of adverse events and adverse drug reactions	—

Contacts

Public ContactYoshitaka Shimizu

Kissei Pharmaceutical Co., Ltd.

rinsyousiken@pharm.kissei.co.jp+81-3-5684-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026