Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451633
Status:
WITHDRAWN
Last Update Posted:
2013-10-31
First Post:
2007-03-21
Brief Title:
The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinsons Disease Who Experience Dyskinesia And Motor Fluctuations
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Randomized Double Blind Placebo-Controlled Study To Investigate The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinsons Disease Who Experience Dyskinesia And Motor Fluctuations
Status:
WITHDRAWN
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study group changed from patients to a healthy volunteers A healthy-volunteer study is being planned to replace 213
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized double blind placebo-controlled study employing a mixed parallel group and fixed sequence cross-over design
Patients will be randomized to one of two treatment groups E2007 or Placebo in a 11 ratio and receive investigational drug treatment concomitant with their standard individualized anti-Parkinsonian therapy for a total of six weeks Investigational drug treatment for patients in the E2007 treatment group will be started 2 mg E2007 od but will be escalated to 4 mg E2007 od after three weeks
Patients will be randomized to one of two treatment groups E2007 or Placebo in a 11 ratio and receive investigational drug treatment concomitant with their standard individualized anti-Parkinsonian therapy for a total of six weeks Investigational drug treatment for patients in the E2007 treatment group will be started 2 mg E2007 od but will be escalated to 4 mg E2007 od after three weeks
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