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

Phase 2

Completed

• Conditions: Spinocerebellar Degeneration
• Interventions: Drug: Placebo; Drug: KPS-0373

• Registration Number: NCT01004016
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

To evaluate the efficacy and safety of KPS-0373 in patients with SCD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-27
• Last Update Posted: 2010-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Japanese SCD patients with mild to moderate 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: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
KPS-0373	KPS-0373	-

Primary Outcome Measures

Name	Time	Method
Upper and lower extremity function	4 weeks + 12 weeks
Scale for Assessment and Rating of Ataxia (SARA)	4 weeks + 12 weeks

Trial Locations

Locations (1)

Japan; 🇯🇵 Japan, Japan