Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199420
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2005-09-12
Brief Title:
A Study of Istradefylline KW-6002 in Treating Patients With Parkinsons Disease on Levodopa
Sponsor:
Kyowa Kirin Inc
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
A 12-week Double Blind Placebo-controlled Randomized Parallel Group Multicenter Fixed Dose Study to Evaluate the Efficacy and Safety of 10 20 and 40 mgd Oral Dose of KW-6002 Istradefylline as Treatment for Parkinsons Disease in Patients With Motor Response Complications on LevodopaCarbidopa Therapy
Status:
COMPLETED
Status Verified Date:
2024-04
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 10 20 and 40 mgd dose 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 10 20 and 40 mgd dose 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 1 to 1 ratio to either istradefylline 10 20 or 40 mg or matching placebo Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess efficacy and safety
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