Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04519645
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2020-07-31
Brief Title:
A Study to Evaluate the Efficacy Safety and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
A Multicenter Open-Label Randomized Active Comparator Study to Evaluate the Efficacy Safety and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
Status:
RECRUITING
Status Verified Date:
2024-05
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:
LENS
Brief Summary:
The purpose of the study is to evaluate the efficacy of lacosamide LCM versus an Active Comparator chosen based on standard of care StOC in severe and nonsevere seizure burden defined as total minutes of electroencephalographic neonatal seizures ENS per hour in neonates with seizures that are not adequately controlled with previous anti-epileptic drug AED treatment
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-001066-10 | EUDRACT_NUMBER | None | None |