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

Last updated: June 25, 2025
Sponsor: Kissei Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Spinocerebellar Disorders

Friedreich's Ataxia

Treatment

KPS-0373

Placebo

Clinical Study ID

NCT07040137
KPS1306
jRCT
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Japanese SCD patients with mild to moderate ataxia

Exclusion

Exclusion Criteria:

  • Patients with secondary ataxia

  • Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Study Design

Total Participants: 142
Treatment Group(s): 2
Primary Treatment: KPS-0373
Phase: 3
Study Start date:
July 01, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Research Site

    Multiple Locations,
    Japan

    Active - Recruiting

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