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

Spinocerebellar Degeneration Clinical Trial

Official title:

An Open-label, Phase II Study of KPS-0373 in Patients With SCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863538
• Other study ID #: KPS1201
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2009
• Last updated: February 1, 2010

Study information

• Verified date: February 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, safety and pharmacokinetics profile of KPS-0373 in patients with SCD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• SCD with mild to moderate ataxia

Exclusion Criteria:

• Patients with secondary ataxia

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinocerebellar Ataxias
• Spinocerebellar Degeneration
• Spinocerebellar Degenerations

Intervention

Drug:
• KPS-0373

Locations

Country	Name	City	State
Japan	Japan	Hokkaido Region
Japan	Japan	Kansai Region
Japan	Japan	Kanto Region

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 the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression		12 weeks	No