Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

Study Overview
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Brief Summary
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The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.

Official Title
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An Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Long-Term Oral Lacosamide for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy

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: Subject completed the SP0961 (NCT01118949) study Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator Exclusion Criteria: Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an ongoing Serious Adverse Event (SAE)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 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>Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses. | Drug: Lacosamide<br>* Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100 mg /day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/ day per week up to a maximum of 800 mg/ day. Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase was followed by a 5-week End-of-Study Phase, during which subjects had to be tapered off Lacosamide at a recommended decrease rate of 200 mg/ day per week.<br>* Other names: Vimpat®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) |  | From Visit 1 to the end of study (Approximately 61 weeks) | 
| Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) |  | From Visit 1 to the end of study (Approximately 61 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Generalized Tonic-Clonic (PGTC) Seizures, Absence Seizures, Myoclonic Seizures, Idiopathic Generalized Epilepsy (IGE)