Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291655
Status:
COMPLETED
Last Update Posted:
2015-05-18
First Post:
2006-02-10
Brief Title:
Follow up Trial for Keppra Levetiracetam as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 NCT00175903
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Multicenter Open-label Follow-up Trial Evaluating the Long-term Safety of Levetiracetam for Patients Suffering From Epilepsy and Coming From the Study N01175 NCT00175903
Status:
COMPLETED
Status Verified Date:
2015-04
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:
For ethical reasons to give opportunity for adult subjects 16 or 18 years suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory open-label trial N01175 NCT00175903 conducted with levetiracetam in monotherapy and who benefited from the treatment to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe
To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes
To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes
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 |
|---|---|---|---|
| EUDRACT NUMBER 2006-000173-29 | None | None | None |