A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Phase 3

Completed

• Conditions: Spinocerebellar Degeneration
• Interventions: Drug: KPS-0373, High dose; Drug: Placebo; Drug: KPS-0373, Low dose

• Registration Number: NCT01970098
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-09
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-25
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KPS-0373	KPS-0373, High dose	-
KPS-0373	KPS-0373, Low dose	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
SARA (Scale for the Assessment and Rating of Ataxia)	24 weeks	The change in the SARA total score at the time of final evaluation

Secondary Outcome Measures

Name	Time	Method
SF-8 (QOL)	24 weeks