Phase 2
Completed N=370
To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Partial Epilepsies
Source: ClinicalTrials.gov NCT00552305 ↗
Enrolled (actual)
370
Serious AEs
33.8%
Results posted
Sep 2011
Primary outcomePrimary: Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years) — 343 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 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years) |
343 | — |
| PRIMARY Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years) |
47 | — |
| PRIMARY Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years) |
125 | — |
| SECONDARY Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years) |
-50.8 | — |
| SECONDARY Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years) |
51.2 | — |
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 (NCT00552305). 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.