Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients

Parkinson's Disease Clinical Trial

— 6002-010  

Official title:

Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957203
• Other study ID #: 6002-010
• Status: Completed
• Phase: Phase 3
• First received: August 7, 2009
• Last updated: August 30, 2012
• Start date: October 2009
• Est. completion date: March 2012

Study information

• Verified date: August 2012
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: March 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Be willing and able to give written informed consent

2. Completion of the study 6002-009

Exclusion Criteria:

1. Mini-mental status examination score of 23 or less

2. Less than 70% of compliance in the study 6002-009

3. Emergency deviation in the study 6002-009

4. Pregnant females

Study Design

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Istradefylline
Oral istradefylline (KW-6002) 20 or 40 mg once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events			Yes
Secondary	Reducing the mean total hours of awake time per day spent in the OFF state			No
Secondary	Reducing the mean percentage of awake time per day spent in the OFF state			No
Secondary	Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)			No
Secondary	Change in Unified Parkinson's Disease Rating Scale (UPDRS)			No
Secondary	Change in the Clinical Global Impression - Improvement scale (CGI-I)			No