Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448539
Status:
TERMINATED
Last Update Posted:
2019-11-22
First Post:
2007-03-15
Brief Title:
Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated early by the sponsor due to the discontinuation of clinical development for rufinamide
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was an open-label extension study in adolescent and adult between 12 and 80 years old participants who had completed their participation in Study E2080-A001-301 The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic seizures in participants who had refractory partial seizures despite treatment with a maximum of three approved antiepileptic drugs AEDs
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 |
|---|---|---|---|
| 2016-004950-14 | EUDRACT_NUMBER | None | None |