Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure

Study Overview
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Brief Summary
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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

Official Title
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A Multicenter, Open Label Study to Evaluate the Tolerability, Safety and Efficacy of Lacosamide (200mg - 400mg/Day) as add-on Therapy for Patients With Partial Onset Epilepsy Using a Flexible Dose-escalation Schedule and Individualized Maintenance Doses

Conditions
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Partial Epilepsies

Intervention / Treatment
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* Drug: Lacosamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacosamide<br>Flexible dosing between 200mg/day and 400mg/day | Drug: Lacosamide<br>* Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks<br>* Other names: Vimpat®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study | Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed. | During the study ( up to 24 - 28 weeks) | 
| Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study | Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed. | During the study (up to 24 - 28 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period | The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100. The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase. | End of Treatment Period (24-week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy treatment., Anti-epileptic drugs, Seizures