Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-13 @ 7:07 AM
Study NCT ID:
NCT00199420
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa
Sponsor:
Kyowa Kirin, Inc.
Organization:
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 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa 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 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.
Detailed Description:
To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's 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:
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?: