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

Phase 3

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Istradefylline

• Registration Number: NCT00957203
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2009-08-11
• Study First Posted: 2009-08-12
• Study Start: 2009-10
• Primary Completion: 2011-09
• Study Completion: 2012-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-30
• Last Update Posted: 2012-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Istradefylline	Istradefylline	-

Primary Outcome Measures

Name	Time	Method
Adverse events

Secondary Outcome Measures

Name	Time	Method
Reducing the mean total hours of awake time per day spent in the OFF state
Reducing the mean percentage of awake time per day spent in the OFF state
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)
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Change in the Clinical Global Impression - Improvement scale (CGI-I)