Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250393
Status:
COMPLETED
Last Update Posted:
2012-08-29
First Post:
2005-11-04
Brief Title:
A Study of Istradefylline KW-6002 for the Treatment of Parkinsons Disease
Sponsor:
Kyowa Kirin Co Ltd
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
Placebo-Controlled Crossover Double-Blind Study of KW-6002Istradefylline in the Treatment of Parkinsons Disease Monotherapy
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 40 mgday doses of istradefylline for the change in Unified Parkinsons Disease Rating Scale UPDRS part-III Motor examination score in patients with Parkinsons disease PD
Detailed Description:
To establish the efficacy of 40mgd doses of istradefylline for the change in UPDRS part-III Motor examination score in patients with Parkinsons disease PD Patients who meet entry criteria will be randomly assigned to receive study drug in 1 of 2 arms Condition A doses of 40mgd istradefylline in Period 1 followed by Condition B matching placebo in Period 2 putting 4 weeks interval phase between two periods or Condition B in Period 1 followed by Condition A in Period 2putting 4 weeks interval phase between two periods Patients will be participated 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