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Clinical Trials in Japan / NCT07040137
Active, not recruiting Phase 3

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

NCT07040137 · tracked via the Priya Life Science Japan tracker
Sponsor
Kissei Pharmaceutical Co., Ltd
Phase
Phase 3
Started
2025-08-15
Last updated
2026-09-04

Condition(s) studied

Spinocerebellar Degeneration

Investigational drug(s) / intervention(s)

KPS-0373Placebo

KPS-0373: Oral administration

Placebo: Oral administration

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change from baseline in SARA total score at 24 weeks of treatment period — Up to 24 weeks
    The SARA is a scale that assesses cerebellar ataxia. An evaluator observes the subject's ability to perform motor activities across in 8 individual items: ("gait: 0-8 points," "stance: 0-6 points," "sitting: 0-4 points," "speech disturbance: 0-6 points," "finger chase: 0-4 points," "nose-finger test: 0-4 points," "fast alternating hand movements: 0-4 points," and "heel-shin slide: 0-4 points." The total SARA score ranges from 0 (no ataxia) to 40 (severe ataxia).

Trial sites (1)

FacilityCityRegionStatus
Research Site Tokyo and Other Japanese Cities Japan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07040137 on ClinicalTrials.gov ↗ ← All trials in Japan