Phase 3
Completed N=308
Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Partial Epilepsies
Source: ClinicalTrials.gov NCT00522275 ↗
Enrolled (actual)
308
Serious AEs
23.1%
Results posted
Nov 2010
Primary outcomePrimary: Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) — 288 subjects
Summary
The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) |
288 | — |
| PRIMARY Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) |
33 | — |
| PRIMARY Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years) |
71 | — |
| SECONDARY Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years) |
-48.5 | — |
| SECONDARY Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years) |
48.2 | — |
Eligibility Criteria
Inclusion Criteria
- Completion of parent clinical trial for treatment of partial seizures
Exclusion Criteria
- Receiving any study drug or experimental device other than lacosamide
- Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event
Data sourced from ClinicalTrials.gov (NCT00522275). 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.