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

Phase 3

Completed

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

• Registration Number: NCT01970124
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-25
• Primary Completion: 2015-05
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Japanese SCD patients with ataxia

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
SARA (Scale for the Assessment and Rating of Ataxia)	52 weeks

Secondary Outcome Measures

Name	Time	Method
SF-8 (QOL)	52 weeks