Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KPS-0373, Placebo.
- Who it may be relevant to
- Registry conditions: Spinocerebellar Degeneration. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase III Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration
Overview
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.
Interventions
- Drug KPS-0373
Oral administration - Drug Placebo
Oral administration
Primary outcome measures
- Change from baseline in SARA total score at 24 weeks of treatment period [Time frame: Up to 24 weeks]
Secondary outcome measures (4)
- Change from baseline in SARA total score [Time frame: Up to 24 weeks]
- Symptom Maintenance Ratio (Ratio of Improvement and Stability Cases) based on SARA total score [Time frame: Up to 24 weeks]
- Change from baseline in SARA individual scores [Time frame: Up to 24 weeks]
- Change from baseline in SF-8 [Time frame: Up to 24 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Research Site — Multiple Locations
Identifiers
NCT: NCT07040137 · KPS1306 · jRCT