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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00957203
Other study ID # 6002-010
Secondary ID
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


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
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