Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360412
Status:
TERMINATED
Last Update Posted:
2014-07-11
First Post:
2006-08-02
Brief Title:
A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinsons Disease Patients With Motor Fluctuations
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Multi-centre Open Label Extension Study to Evaluate the Long-term Safety Tolerability and Efficacy of E2007 as an Adjunctive Therapy 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:
Patients who have completed one of the core trials E2007-E044-301 or E2007-A001-302 and who meet inclusionexclusion criteria will be enrolled and will enter the Titration Phase lasting 4 weeks weeks 0-3 followed by the Maintenance Phase lasting 52 weeks weeks 4-56 All patients will receive active study drug During the Titration Phase patients will receive E2007 2 mg once daily od for 2 weeks followed by 4 mg od for 2 weeks During the Maintenance Phase patients will receive 4 mg od Patients not tolerating the study drug at 4 mg will be allowed to down titrate to 2 mg Patients not tolerating 2 mg will be withdrawn from the study
Patients will have visits at 2 4 8 20 32 44 and 56 weeks after study entry In addition a follow-up visit will occur 4 weeks after study treatment has ended week 60
A home diary will be completed in which patients rate themselves as either
1 OFF
2 ON without dyskinesia
3 ON with non-troublesome dyskinesias
4 ON with troublesome dyskinesias
5 Asleep
These entries will be completed every half hour during the waking day and will be completed for 3 consecutive days following the visits at weeks 4 8 20 32 and 44 and three days prior to the visits at weeks 56 and 60 At entry into the study week 0 and at weeks 8 20 32 44 and 56 the Unified Parkinsons Disease Rating Scale UPDRS Clinicians Global Impression of Change CGIC and Clinical Global Impression of Tolerance CGIT will be performed
Patients will have visits at 2 4 8 20 32 44 and 56 weeks after study entry In addition a follow-up visit will occur 4 weeks after study treatment has ended week 60
A home diary will be completed in which patients rate themselves as either
1 OFF
2 ON without dyskinesia
3 ON with non-troublesome dyskinesias
4 ON with troublesome dyskinesias
5 Asleep
These entries will be completed every half hour during the waking day and will be completed for 3 consecutive days following the visits at weeks 4 8 20 32 and 44 and three days prior to the visits at weeks 56 and 60 At entry into the study week 0 and at weeks 8 20 32 44 and 56 the Unified Parkinsons Disease Rating Scale UPDRS Clinicians Global Impression of Change CGIC and Clinical Global Impression of Tolerance CGIT will be performed
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 |
|---|---|---|---|
| 2006-002339-26 | EUDRACT_NUMBER | None | None |