Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360308
Status:
TERMINATED
Last Update Posted:
2014-07-11
First Post:
2006-08-02
Brief Title:
Efficacy Safety and Tolerability of E2007 in Levodopa Treated Parkinsons Disease Patients With Motor Fluctuations
Sponsor:
Eisai Limited
Organization:
Eisai Inc
Study Overview
Official Title:
A Multi-centre Randomised Double-blind Placebo and Entacapone Controlled Parallel Group Study of the Efficacy Safety and Tolerability of E2007 in Levodopa Treated Parkinsons Disease Patients With Motor Fluctuations
Status:
TERMINATED
Status Verified Date:
2013-08
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:
Randomised double-blind double dummy parallel group design Following the screening period patients will be randomised at the baseline visit in a 111 manner to one of three treatment arms 4 mg E2007 200 mg entacapone with each dose of levodopa or placebo The first 4 weeks of the double blind phase will be used to titrate patients on the E2007 arm from 2 mg up to the maintenance dose of 4 mg Patients randomised to entacapone or placebo will have dummy up titrations to maintain the blind Following this titration phase patients will remain on the maintenance dose for a further 14 weeks
Patients will have visits at 2 4 6 10 14 and 18 weeks after baseline A follow up visit will be performed at Week 22
A home diary will be completed in which patients rate themselves as either
1 OFF
2 ON without dyskinesias
3 ON with non-troublesome dyskinesias
4 ON with troublesome dyskinesias
5 Asleep
These entries will be completed every 30 minutes during the waking day and will be completed for three consecutive days immediately prior to visits at Baseline Weeks 6 10 18 and 22
At Baseline Day 0 week 10 and 18 the Unified Parkinsons Disease Rating Scale UPDRS - Parts I II III and IV will be performed
At the end of the treatment period Week 18 patients will undergo final efficacy and safety assessments and will stop taking the study medication they were receiving They will be seen 4 weeks later for a follow up visit
Patients will have visits at 2 4 6 10 14 and 18 weeks after baseline A follow up visit will be performed at Week 22
A home diary will be completed in which patients rate themselves as either
1 OFF
2 ON without dyskinesias
3 ON with non-troublesome dyskinesias
4 ON with troublesome dyskinesias
5 Asleep
These entries will be completed every 30 minutes during the waking day and will be completed for three consecutive days immediately prior to visits at Baseline Weeks 6 10 18 and 22
At Baseline Day 0 week 10 and 18 the Unified Parkinsons Disease Rating Scale UPDRS - Parts I II III and IV will be performed
At the end of the treatment period Week 18 patients will undergo final efficacy and safety assessments and will stop taking the study medication they were receiving They will be seen 4 weeks later for a follow up visit
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-002937-20 | EUDRACT_NUMBER | None | None |