Phase 3
Completed N=376
Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
Source: ClinicalTrials.gov NCT00515619 ↗Enrolled (actual)
376
Serious AEs
23.1%
Results posted
Sep 2011
Primary outcomePrimary: Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years) — 311 Subjects
Summary
The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years) |
311 | — |
| PRIMARY Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years) |
33 | — |
| PRIMARY Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years) |
87 | — |
| SECONDARY Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years) |
-49.9 | — |
| SECONDARY Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years) |
50.0 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosis of Epilepsy
- completion of double blind trial
Exclusion Criteria
- taking other investigational drug than Lacosamide
- meeting withdrawal criteria from double blind trial
Data sourced from ClinicalTrials.gov (NCT00515619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.