Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 10:53 AM
Study NCT ID:
NCT00957203
Status:
COMPLETED
Last Update Posted:
2012-08-31
First Post:
2009-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients
Sponsor:
Kyowa Kirin Co., Ltd.
Organization:
Study Overview
Official Title:
Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
6002-010
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: