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NCT01964560 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
A Phase 3 study, sponsored by UCB Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 540
- Enrollment target
NCT01964560: Completed Phase 3 study, sponsored by UCB Biosciences.
NCT01964560 is a Phase 3 study that has completed, run by UCB Biosciences. The registered enrollment target is 540 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01964560, a Phase 3 study, has completed, sponsored by UCB Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 540 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-eme
Interventions
- DRUG Lacosamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2014-08-13 |
| Est. Completion | 2022-04-13 |
| Phase | Phase 3 |
What the finished NCT01964560 record still lists
NCT01964560 is an interventional study that assigns participants to a tested intervention. The registered 540 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 (30% lower).
The record links to 0 conditions, and to 1 intervention - of which Lacosamide is the first listed.
NCT01964560 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01964560 about?
NCT01964560 is a clinical study titled "A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures". The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
What is the current status of trial NCT01964560?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2014-08-13. Estimated completion is 2022-04-13.
What interventions are being tested in trial NCT01964560?
The interventions under investigation include: Lacosamide (DRUG).
Who is sponsoring clinical trial NCT01964560?
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 NCT01964560's enrollment target sits among peer trials
540 694th of 2000 higher than 1,301 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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