Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-02-21 @ 11:15 AM
Study NCT ID:
NCT03370120
Status:
TERMINATED
Last Update Posted:
2021-12-29
First Post:
2017-12-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
Sponsor:
UCB Biopharma SRL
Organization:
Study Overview
Official Title:
An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy
Status:
TERMINATED
Status Verified Date:
2021-11
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 the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-003241-26 | EUDRACT_NUMBER | None | View |