Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199368
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2005-09-12
Brief Title:
An Extension of Istradefylline in Parkinsons Disease Patients Who Have Completed Studies 6002-EU-007 6002-US-013 or 6002-US-018
Sponsor:
Kyowa Kirin Inc
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
A Long-Term Multicenter Open-Label Safety Study With Oral 20 or 40 mgd Doses of KW-6002 Istradefylline 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:
This is a 1-year open-label long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007 6002-US-013 or 6002-US-018
Detailed Description:
Patients with Parkinsons disease with motor complications on levodopa therapy who completed the prior double-blind studies 6002-EU-007 6002-US-013 or 6002-US-018 are eligible to enter into this 1-year long-term open safety study with a starting istradefylline dose of 40mg per day
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