Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199355
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2005-09-12
Brief Title:
A Study of Istradefylline KW-6002 for the Treatment of Parkinsons Disease in Patients Taking Levodopa
Sponsor:
Kyowa Kirin Co Ltd
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
Placebo-Controlled Double-Blind Exploratory Study of KW-6002Istradefylline in the Treatment of Parkinsons Disease Adjunctive Therapy to Levodopa
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:
None
Brief Summary:
To establish the efficacy of 20 mgday and 40 mgday doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinsons disease PD treated with levodopa
Detailed Description:
To establish the efficacy of 20 mgd and 40mgd doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinsons disease PD treated with levodopa Patients who meet entry criteria will be randomized in a 111 ratio to double blind treatment with oral doses of 20 or 40mgd istradefylline or matching placebo Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline
Study Oversight
Has Oversight DMC:
None
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?:
None