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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: Clinical Trial Phase 2 study, sponsored by UCB Biopharma SRL.
NCT04519645 is a Phase 2 study that was terminated before completion, run by UCB Biopharma SRL. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Baseline seizure burden was defined as seizure burden measured on the continuous video-EEG (total electroencephalographic neonatal seizures (ENS) in minutes per hour) during a period of up to 2 hours immediately prior to the first administration of study drug. An ENS was defined as an EEG seizure lasting for at least 10 seconds on video-EEG. The seizure burden in the Evaluation Period was calculated as the total duration of seizures between 1 and 3 hours after the first dose of study medication
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 |
Why NCT04519645 stopped before completion
NCT04519645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Active Comparator is the first listed.
NCT04519645 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04519645's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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