A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures

Phase 3

Completed

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization.

Recruitment & Eligibility

Inclusion Criteria

Subject has had an Electroencephalogram (EEG) and a brain Computerized Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam consistent with a Diagnosis of Epilepsy with Partial-Onset Seizures according to the International Classification of Epileptic Seizures (1981)
Subject must have been observed to have Partial-Onset Seizures for at least the previous 2 years despite prior therapy with at least 2 Anti-Epileptic Drugs (AEDs)(concurrently or sequentially) and must have been observed to have on average at least 4 Partial-Onset Seizures per 28 days with a seizure-free phase no longer than 21 days in the 8-Week Period prior to entry into the Baseline Period. In the case of Simple Partial Seizures, only those with motor signs will be counted towards meeting the inclusion criterion
Subjects must be on a stable dose regimen of at least 1, but no more than 3 AEDs (concurrent stable Vagus Nerve Stimulation (VNS) is not counted as an AED). The VNS must have been in place for at least 6 months prior to study entry. The dosage of concomitant AED therapy and the settings of the VNS must be kept constant for a period of at least 4 weeks prior to entry into the Baseline Period
Minimum Body Weight of 40 kg

Exclusion Criteria

Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) or has a suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
Subject has a current or previous diagnosis of Pseudo-Seizures, Conversion Disorders, or other non-epileptical events that could be confused with Seizures
Subject has Seizures that are uncountable due to Clustering (ie, an episode lasting less than 30 minutes in which several Seizures occur with such frequency that the initiation and completion of each individual Seizure cannot be distinguished) during the 8-Week Period prior to Visit 1
Subject has a history of Primary Generalized Seizures
Subject with a history of Status Epilepticus within the 12-Months Period prior to Visit 1
Subject who underwent surgery for Epilepsy within the 2 Years Period prior to Visit 1
Subjects with cardiac, renal, hepatic, endocrinological dysfunction or psychiatric illness that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo for 16 weeks.
Lacosamide 200 mg/day	Lacosamide 50 mg	Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.
Lacosamide 200 mg/day	Lacosamide 100 mg	Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.
Lacosamide 400 mg/day	Lacosamide 100 mg	Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.
Lacosamide 400 mg/day	Lacosamide 50 mg	Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period	8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)	Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.

Secondary Outcome Measures

Name	Time	Method
The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)	8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)
Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period	8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)	Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.
Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)	8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)	Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.

Locations (76): 86026
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Beijing, China
86027
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Beijing, China
86015
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Changchun, China
86005
🇨🇳
Chengdu, China
86032
🇨🇳
Chengdu, China
86006
🇨🇳
Chongqing, China
86031
🇨🇳
Dalian, China
86009
🇨🇳
Guanghzou, China
86007
🇨🇳
Guangzhou, China
86008
🇨🇳
Guangzhou, China
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86026
🇨🇳Beijing, China