A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment

The primary objective of this study is to **assess** the long-term use of **lacosamide** oral solution, dosed at 2mg/kg/day to 12mg/kg/day, in pediatric participants with **epilepsy** who have completed the clinical trials NCT01964560 (EP0034) or NCT00938912 (SP848). This evaluation is clinically relevant as it aims to determine the safety and efficacy of prolonged lacosamide administration in managing epilepsy in children, which is crucial for optimizing therapeutic strategies and improving patient outcomes.

The clinical trial involves a total of **30 participants** diagnosed with **epilepsy**. The study population consists of both male and female pediatric subjects, all under the age of 6 years at the time of enrollment. Participants were selected based on their completion of previous studies, specifically NCT01964560 (EP0034) or NCT00938912 (SP848), and are expected to benefit from continued participation as assessed by the investigator. The trial focuses on assessing the long-term use of lacosamide oral solution, with dosages ranging from 2mg/kg/day to 12mg/kg/day. The study includes a vulnerable population, given the young age of the participants. No specific lifestyle considerations such as diet or physical activity are highlighted in the available data.

The clinical trial is designed to assess the long-term use of **lacosamide** oral solution in pediatric participants with **epilepsy** who have completed previous studies NCT01964560 (EP0034) or NCT00938912 (SP848). This is an open-label, follow-up study, which means that both the researchers and participants know which treatment is being administered. The trial is not randomized or blinded, as it is an extension of prior studies. The trial is expected to run until August 31, 2025, with recruitment having started on December 28, 2020.

Participants will be administered lacosamide syrup orally, with doses ranging from 2 mg/kg/day to 12 mg/kg/day. The maximum daily dose is set at 600 mg, and the treatment period can extend up to 205 days. The primary endpoints include the incidence of treatment-emergent adverse events (TEAEs), withdrawals due to TEAEs or serious adverse events (SAEs), and the modal and maximum daily doses during the study. There are no secondary endpoints specified.

The study involves several key visits. Initially, there is an inclusion (screening) visit to confirm eligibility, which requires participants to be under 6 years of age and to have completed the specified prior studies. Follow-up visits will be scheduled to monitor the safety and efficacy of the treatment, as well as to record any adverse events. The end-of-study visit will conclude the participant's involvement, assessing the overall outcomes and any long-term effects of the treatment.

Participant involvement is expected to last for the duration of the treatment period, up to 205 days, unless early termination is warranted. Conditions for early termination include the occurrence of serious adverse events or if the participant is no longer expected to benefit from the study, as determined by the investigator. The study is conducted under the sponsorship of UCB BIOSCIENCES, INC., and the product is not classified as a pediatric formulation or an orphan drug.

The clinical trial involves the administration of **lacosamide** in the form of a **syrup**. The experimental medication, identified as **lacosamide PRD236256**, is produced by UCB BIOSCIENCES, INC. The active substance, **lacosamide**, is of chemical origin. The pharmaceutical form of the medication is a syrup, designed for oral administration. The dosing regimen for this trial involves a daily dosage ranging from 2 mg/kg to 12 mg/kg, with a maximum daily dose of 600 mg. The treatment period is set for a maximum of 205 days. The medication is intended for pediatric participants with epilepsy who have completed previous studies, specifically NCT01964560 (EP0034) or NCT00938912 (SP848).

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The focus is solely on the long-term use of the oral lacosamide syrup. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the prescribed regimen. The trial aims to assess the long-term safety and efficacy of lacosamide in the specified patient population.

The efficacy of the clinical trial will be assessed through the evaluation of several primary endpoints. These include the incidence of treatment-emergent adverse events (TEAEs), withdrawals from the study due to TEAEs, and withdrawals due to Serious Adverse Events (SAEs). Additionally, the modal daily dose and the maximum daily dose during the study will be monitored. The trial is designed to assess the long-term use of oral **lacosamide** in pediatric participants with epilepsy who have completed previous studies EP0034 or SP848. The dosing regimen for lacosamide ranges from 2 mg/kg/day to 12 mg/kg/day. The study is open-label and follows participants who have already been exposed to lacosamide treatment, allowing for the collection of long-term safety and efficacy data. The trial is expected to conclude by August 31, 2025.