Ignite Creation Date:
2024-05-06 @ 12:20 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03739840
Status:
TERMINATED
Last Update Posted:
2022-12-21
First Post:
2018-11-09
Brief Title:
A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Parallel-Group Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy
Status:
TERMINATED
Status Verified Date:
2022-12
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:
DUET
Brief Summary:
The purpose of the study is to evaluate the efficacy safety and tolerability of the 3 selected dose regimens of padsevonil PSL administered concomitantly with up to 3 anti-epileptic drugs AEDs compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002303-33 | EUDRACT_NUMBER | None | None |