Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

Study Overview
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Brief Summary
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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

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

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: 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

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>Up to 800 mg/day lacosamide (flexible dosing) | Drug: lacosamide<br>* 50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial<br>|

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 (Maximum 6 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 (Maximum 6 years) | 
| Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 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 (Maximum 6 years) | 
| Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years) | Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | During the Treatment Period (Maximum 6 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years) | Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency. | Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years) | 
| Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 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. | Treatment Period (Maximum 6 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adjunctive treatment in epilepsy, add-on treatment for epilepsy, partial seizures, AEDs, antiepileptic drugs, seizures