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NCT04519645 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
A Phase 2 study, sponsored by UCB Biopharma SRL.
- Terminated
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT04519645 is a Phase 2 study that was terminated before completion, run by UCB Biopharma SRL. The registered enrollment target is 29 participants.
The verdict
NCT04519645, a Phase 2 study, was terminated before completion, sponsored by UCB Biopharma SRL.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study 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.
Interventions
- OTHER Active Comparator
- DRUG Lacosamide intravenous
- DRUG Lacosamide oral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2021-03-31 |
| Est. Completion | 2024-10-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04519645
The ClinicalTrials.gov registry entry for NCT04519645 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCB Biopharma SRL, which has 82 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Active Comparator is the first listed.
NCT04519645 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04519645 about?
NCT04519645 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures". 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 ar...
What is the current status of trial NCT04519645?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2021-03-31. Estimated completion is 2024-10-31.
What interventions are being tested in trial NCT04519645?
The interventions under investigation include: Active Comparator (OTHER), Lacosamide intravenous (DRUG), Lacosamide oral (DRUG).
Who is sponsoring clinical trial NCT04519645?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
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