Phase 4
Completed N=100
Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
Partial Epilepsies
Source: ClinicalTrials.gov NCT01235403 ↗
Enrolled (actual)
100
Serious AEs
3.0%
Results posted
Jan 2013
Primary outcomePrimary: Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study — 64 subjects
Summary
To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy.
Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study |
64 | — |
| PRIMARY Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study |
14 | — |
| SECONDARY Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period |
73 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has a diagnosis of partial-onset epilepsy with or without secondary generalization
- Currently taking 1 to 3 concomitant marketed antiepileptic drugs
- 18 years and older at study entry
Exclusion Criteria
- Previous use of lacosamide
- Hypersensitivity to any component of lacosamide
- Patients with partial onset seizures not clearly identifiable
- History of generalized epilepsy
- History of status epilepticus within last 12 months
- Uncountable seizures due to clustering within last 12 weeks
- Non epileptic events, including pseudoseizures, conversion disorder that could be confused with seizures
- History of drug or alcohol abuse
- History of suicide attempt
- Progressive cerebral disease
- Concomitant treatment of felbamate
- Prior or concomitant vigabatrin use
- Under legal protection
Data sourced from ClinicalTrials.gov (NCT01235403). 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.