Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

Study Overview
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Brief Summary
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The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.

Official Title
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An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Lacosamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 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>50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing | Drug: Lacosamide<br>* 50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial<br>* Other names: LCM;|

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 Treatment Period (up to 5.5 Years) | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | During the Treatment Period (up to 5.5 years) | 
| Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years) | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | During the Treatment Period (up to 5.5 years) | 
| Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years) | A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention. | During the Treatment Period (up to 5.5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years) | Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency. Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency. | Baseline, Treatment Period (up to 5.5 years) | 
| Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years) | At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency | Treatment Period (up to 5.5 years) |