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NCT02477839 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures
A Phase 3 study, sponsored by UCB Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 255
- Enrollment target
NCT02477839: Completed Phase 3 study, sponsored by UCB Biosciences.
NCT02477839 is a Phase 3 study that has completed, run by UCB Biosciences. The registered enrollment target is 255 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02477839, a Phase 3 study, has completed, sponsored by UCB Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 255 participants
- Enrollment target
Study Summary
The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled partial-onset seizures.
Primary Outcome
The change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-electroencephalogram (EEG) compared to the End-of-Baseline Period video-EEG. Seizure frequency was analyzed using an analysis of covariance (ANCOVA) with terms for treatment, pooled randomized age stratum, pooled center, and Baseline seizure ADF. Seizure ADF was log transformed using the transformation of ln(X+1), where X is the seizure ADF. Baseline seizure ADF was log transformed. Le
Interventions
- OTHER Placebo
- DRUG Lacosamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2015-06-05 |
| Est. Completion | 2020-05-28 |
| Phase | Phase 3 |
What the finished NCT02477839 record still lists
NCT02477839 is an interventional study that assigns participants to a tested intervention. The registered 255 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02477839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02477839 about?
NCT02477839 is a clinical study titled "Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures". The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled partial-onset seizures.
What is the current status of trial NCT02477839?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 255 participants. The study started on 2015-06-05. Estimated completion is 2020-05-28.
What interventions are being tested in trial NCT02477839?
The interventions under investigation include: Placebo (OTHER), Lacosamide (DRUG).
Who is sponsoring clinical trial NCT02477839?
This trial is sponsored by UCB Biosciences, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02477839's enrollment target sits among peer trials
255 1242nd of 2000 higher than 756 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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