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NCT02408523 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
A Phase 3 study, sponsored by UCB Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 242
- Enrollment target
NCT02408523: Completed Phase 3 study, sponsored by UCB Biosciences.
NCT02408523 is a Phase 3 study that has completed, run by UCB Biosciences. The registered enrollment target is 242 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02408523, a Phase 3 study, has completed, sponsored by UCB Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 242 participants
- Enrollment target
Study Summary
Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.
Primary Outcome
The primary efficacy variable was the time to the second primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio. The indicated measured values are the observed number of events of second PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis. The hazard ratio compares 2 treatment groups for the times to a specified number
Interventions
- OTHER Placebo Tablet
- DRUG Lacosamide Tablet
- DRUG Lasosamide Oral Solution
- OTHER Placebo Oral Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-06 |
| Phase | Phase 3 |
What the finished NCT02408523 record still lists
NCT02408523 is an interventional study that assigns participants to a tested intervention. The registered 242 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 (69% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo Tablet is the first listed.
NCT02408523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02408523 about?
NCT02408523 is a clinical study titled "A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications". Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug...
What is the current status of trial NCT02408523?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 242 participants. The study started on 2015-04. Estimated completion is 2019-06.
What interventions are being tested in trial NCT02408523?
The interventions under investigation include: Placebo Tablet (OTHER), Lacosamide Tablet (DRUG), Lasosamide Oral Solution (DRUG), Placebo Oral Solution (OTHER).
Who is sponsoring clinical trial NCT02408523?
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 NCT02408523's enrollment target sits among peer trials
242 1270th of 2000 higher than 729 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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