A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Phase 2

Completed

• Conditions: SCD
• Interventions: Drug: KPS-0373; Drug: Placebo

• Registration Number: NCT01384435
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-29
• Status Verified: 2012-03
• Last Update Submitted: 2012-11-29
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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, lowest dose	KPS-0373	-
KPS-0373, 2nd lowest dose	KPS-0373	-
KPS-0373, 2nd highest dose	KPS-0373	-
Placebo	Placebo	-
KPS-0373, highest dose	KPS-0373	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Scale for the assessment and rating of ataxia (SARA)	24 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in patient improvement impression of activities of daily living	24 weeks

Trial Locations

Locations (1)

Japan; 🇯🇵 Tokyo and Other Japanese City, Japan

Japan

🇯🇵Tokyo and Other Japanese City, Japan