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

Spinocerebellar Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970098
• Other study ID #: KPS1301
• Status: Completed
• Phase: Phase 3
• Start date: October 9, 2013
• Est. completion date: January 2015

Study information

• Verified date: December 2018
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinocerebellar Ataxias
• Spinocerebellar Degeneration
• Spinocerebellar Degenerations

Intervention

Drug:
• KPS-0373, High dose
28 weeks
• KPS-0373, Low dose
28 weeks
• Placebo
28 weeks

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)	The change in the SARA total score at the time of final evaluation	24 weeks
Secondary	SF-8 (QOL)		24 weeks