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NCT00938912 · ClinicalTrials.gov registry record · Phase 2
An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy
A Phase 2 study, sponsored by UCB Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 366
- Enrollment target
NCT00938912: Completed Phase 2 study, sponsored by UCB Biosciences.
NCT00938912 is a Phase 2 study that has completed, run by UCB Biosciences. The registered enrollment target is 366 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (175% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00938912, a Phase 2 study, has completed, sponsored by UCB Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 366 participants
- Enrollment target
Study Summary
SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as adjunctive therapy.
Primary Outcome
An AE is any untoward medical occurrence in a participant or clinical investigation study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Interventions
- DRUG Lacosamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2009-12-09 |
| Est. Completion | 2021-05-18 |
| Phase | Phase 2 |
What the finished NCT00938912 record still lists
NCT00938912 is an interventional study that assigns participants to a tested intervention. The registered 366 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (175% higher).
The record links to 0 conditions, and to 1 intervention - of which Lacosamide is the first listed.
NCT00938912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00938912 about?
NCT00938912 is a clinical study titled "An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy". SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as adjunctive therapy.
What is the current status of trial NCT00938912?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 366 participants. The study started on 2009-12-09. Estimated completion is 2021-05-18.
What interventions are being tested in trial NCT00938912?
The interventions under investigation include: Lacosamide (DRUG).
Who is sponsoring clinical trial NCT00938912?
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 NCT00938912's enrollment target sits among peer trials
366 121st of 2000 higher than 1,880 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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