Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199433
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2005-09-12
Brief Title:
A Study of Istradefylline KW-6002 as Monotherapy in Parkinsons Disease PD Patients
Sponsor:
Kyowa Kirin Inc
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
A Phase 2 Double-blind Placebo-controlled Randomized Parallel-Group Multicenter Study to Evaluate the Efficacy and Safety of 40mgDay KW-6002 Istradefylline as Monotherapy in Subjects With Parkinsons Disease
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 primary purpose of this study is to evaluate the efficacy safety and tolerability of 40 mg per day of istradefylline KW6002 as monotherapy in patients with Parkinsons disease
Detailed Description:
Parkinsons disease is a progressive disease which results in deterioration of motor function and is the result of dopamine depletion in specific brain structures Current therapeutic approaches include dopamine replacement and the use of dopamine receptor agonist drugs These therapies are effective but may be associated with unwanted complications like wearing off phenomena and involuntary abnormal movements dyskinesia Istradefylline may provide a nondopaminergic approach to the treatment of Parkinsons disease
This study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of Parkinsons disease with placebo
This study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of Parkinsons disease with 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