A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures

A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatient hospitalization or prolongation of hospitalization. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.

Time frame: From Week 0 to the End of Safety Follow-Up (up to Week 104)

Population: The SS included all enrolled study participants who took at least 1 dose of LCM in this long-term extension study.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to study discontinuation. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.

Time frame: From Week 0 to the End of Safety Follow-Up (up to Week 104)

Population: The SS included all enrolled study participants who took at least 1 dose of LCM in this long-term extension study. Here, only those participants who discontinued the study due to TEAEs starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose of LCM are reported.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.

Time frame: From Week 0 to the End of Safety Follow-Up (up to Week 104)

Population: The Safety Set (SS) included all enrolled study participants who took at least 1 dose of LCM in this long-term extension study.

The number of seizure-free days was the total number of days within an interval for which daily diary data were available and no seizures were reported. The percentage of seizure-free days was computed as 100 times the number of seizure-free days in the interval divided by the number of days in the interval for which daily diary data were available. Percentage of seizure-free days was measured using data obtained from participant diaries from EP0034 and is presented for the overall Treatment only.

Time frame: From Week 0 to End of Treatment (up to Week 96)

Population: The Full Analysis Set (FAS) was used for the analysis of seizure data and included all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Study participants whose efficacy data could not be source verified were excluded from the FAS. Here, Number of participants analyzed included those participants who were evaluable for the assessment.