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

Spinocerebellar Degeneration Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Crossover Study, Followed by Open-label Study of KPS-0373 in Patients With SCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004016
• Other study ID #: KPS1202
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2009
• Last updated: September 27, 2010

Study information

• Verified date: September 2010
• 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinocerebellar Ataxias
• Spinocerebellar Degeneration
• Spinocerebellar Degenerations

Intervention

Drug:
• KPS-0373

• Placebo

Locations

Country	Name	City	State
Japan	Japan	Japan

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	Scale for Assessment and Rating of Ataxia (SARA)		4 weeks + 12 weeks	No
Primary	Upper and lower extremity function		4 weeks + 12 weeks	No