Health Trials

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

ConditionSpinocerebellar Degeneration
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKissei Pharmaceutical Co., Ltd.

About this trial

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

Qualifiers

Japanese SCD patients with mild to moderate ataxia

Disqualifiers

Patients with secondary ataxia

Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Trial design

Treatments tested in this trial

  • KPS-0373
  • Placebo

Treatment groups

142 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Research SiteRecruiting Multiple LocationsJapanJapan

Sponsors and collaborators

Kissei Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov