A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Spinocerebellar Degeneration Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970137
• Other study ID #: KPS1304
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2013
• Last updated: April 15, 2016

Study information

• Verified date: April 2016
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: October 2014
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Japanese SCD patients with ataxia (Experience of clinical trials of KPS-0373)

Exclusion Criteria:

• Patients with secondary ataxia

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

• Discontinuations in another clinical trials caused by side effects

Study Design

N/A

Related Conditions & MeSH terms

• Spinocerebellar Ataxias
• Spinocerebellar Degeneration
• Spinocerebellar Degenerations

Intervention

Drug:
• KPS-0373, High dose

• KPS-0373, Low dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARA (Scale for the Assessment and Rating of Ataxia)		24 weeks	No
Secondary	SF-8 (QOL)		24 weeks	No