Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures

Phase 4

Completed

Brief Summary: To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

Detailed Description: The study consisted of 3 Periods: Period 1: a 1-week Screening Phase, Period 2: a 30-week Treatment Phase (consisting of a 6-week Titration Phase and a 24-week Maintenance Phase), and Period 3: a 3-week Taper/Safety Follow-Up Phase.

Recruitment & Eligibility

Inclusion Criteria

Group 1:

Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
Currently taking adequate monotherapy (defined as a single Antiepileptic Drug (AED) for at least 28 days prior to Screening) and has no history of AED polytherapy. Prior use of rescue medication (short-term intermittent use) is acceptable
Epilepsy diagnosis should be ≤24 months at the time of the Screening Visit
The minimum allowed seizure frequency at any time during the 12 weeks prior to the Screening Visit is ≥3 partial-onset seizures

Group 2:

Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
Currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens (concurrently or sequentially)
Epilepsy diagnosis should be ≥5 years at the time of the Screening Visit
The minimum allowed seizure frequency during the 12 weeks prior to the Screening Visit is ≥1 partial-onset seizure per 28 days

Exclusion Criteria

Previous use of Lacosamide
History of seizure disorder characterized primarily by isolated auras
History of primary generalized seizures
History of status epilepticus within last 12-months
History of cluster seizures during the 12 week period prior to Visit 1
Nonepileptic events, including pseudoseizures that could be confused with seizure
Lifetime history of suicide attempt or suicidal ideation in the past 6 months
Hypersensitivity to any component of Lacosamide
History of drug or alcohol abuse
History of an acute or subacutely progressive Central Nervous System (CNS) disease
Undergone cranial surgery within the last year prior to study entry
Concomitant treatment of Felbamate or previous Felbamate therapy within the last 6 months
Prior or concomitant Vigabatrin use

Arm && Interventions

Group	Intervention	Description
First Add-on	Lacosamide	Lacosamide added to first adequate monotherapy (no history of Antiepileptic Drug \[AED\] polytherapy) and epilepsy diagnosis \< or = 24 months at Screening.
Later Add-on	Lacosamide	Lacosamide added to 1 to 3 Antiepileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis \> or = 5 years at Screening.

Primary Outcome Measures

Name	Time	Method
The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase	From Week 7 (end of Week 6) to end of Week 18	A subject will be considered seizure-free if the subject completes the first 12 weeks of the Maintenance Phase, reports zero seizures, and has no seizure data missing for any day during the period of time. This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn.

Secondary Outcome Measures

Name	Time	Method

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Irvine, California, United States
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Rancho Mirage, California, United States
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Destin, Florida, United States
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Hollywood, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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