Ignite Creation Date:
2024-05-06 @ 7:54 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02625090
Status:
TERMINATED
Last Update Posted:
2022-03-09
First Post:
2015-12-04
Brief Title:
An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
An Open-label Multicenter Extension Study to Evaluate the Long-term Safety Tolerability and Efficacy of UCB0942 When Used as Adjunctive Therapy for Partial-onset Seizures in Adult Subjects With Highly Drug-resistant Focal Epilepsy
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on available data UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of study EP0073 is to assess the long-term safety tolerability and efficacy during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant focal epilepsy Also the effects of UCB0942 on the patients quality of life will be explored
Detailed Description:
For those subjects who benefit substantially from UCB0942 in the multicenter randomized double-blind placebo-controlled parallel group study EP0069 the current open-label extension study EP0073 will provide an opportunity to continue UCB0942 treatment after a careful evaluation of the individual benefit-risk balance and with close monitoring of safety tolerability and efficacy of long-term study treatment
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 |
|---|---|---|---|
| 2015-001268-20 | EUDRACT_NUMBER | None | None |