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

NCT07040137 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-06-27

No results posted yet for this 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.

Conditions

  • Spinocerebellar Degeneration

Interventions

DRUG

KPS-0373

Oral administration

DRUG

Placebo

Oral administration

Sponsors & Collaborators

  • Kissei Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Japan

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07040137 on ClinicalTrials.gov