Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199394
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2005-09-12
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:
A 16-week Double-Blind Placebo-Controlled Randomised Parallel-Group Multicentre International Study to Evaluate the Efficacy and Safety of 40 mgDay KW-6002 Istradefylline and That of Entacapone Versus Placebo as Treatment for Parkinsons Disease in Patients With Motor Response Complications on Levodopa 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:
The purpose of this study is to evaluate the efficacy of 40 mg a day of istradefylline KW-6002 for reducing the percentage of awake time spent in the OFF state in patients with advanced Parkinsons disease treated with levodopa
Detailed Description:
Parkinsons disease PD is a progressive motor disease characterized by bradykinesia or akinesia rigidity and resting tremor Levodopa is still the most widely used treatment for PD but as the disease progresses the drug tends to become less helpful This is because of the development of motor response complications such as end-of-dose deterioration or wearing-off peak dose dyskinesias and ON-OFF phenomenon
Comparisons The safety of 40 mgd istradefylline and the efficacy for reducing the percentage of OFF time in patients with advanced PD treated with levodopa will be compared to placebo The safety and efficacy of Entacapone will also be compared to placebo
Comparisons The safety of 40 mgd istradefylline and the efficacy for reducing the percentage of OFF time in patients with advanced PD treated with levodopa will be compared to placebo The safety and efficacy of Entacapone will also be compared to placebo
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