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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
548
* Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use
* Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use
Matching oral Placebo tablets twice daily for 16 weeks.
Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
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.
Time frame: 8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)
The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)
Time frame: 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
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.
Time frame: 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)
Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)
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.
Time frame: 8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)
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