Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427011
Status:
TERMINATED
Last Update Posted:
2013-02-11
First Post:
2007-01-24
Brief Title:
A Study of E2007 In Patients With Parkinsons Disease
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety Tolerability and Efficacy of E2007 In Patients With Parkinsons Disease Who Experience End-of-Dose Wearing-Off Motor Fluctuations
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped due to lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase IIb open-label extension study for patients with Parkinsons Disease All patients will receive active study drug The study will involve outpatient visits only Patients who completed Study E2007-A001-214 Cohorts I and II and who meet inclusionexclusion criteria will be enrolled and enter the 12-week Titration Phase from Dispense Study Drug at Week 0 Visit 2 through Week 12 Visit 7 followed by the Maintenance Phase from Week 12 Visit 7 to end of study
Detailed Description:
None
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