Long-Term Safety Study of Lacosamide for Children with Epilepsy

3 1 1

What is this study about?

This clinical trial is focused on studying the long-term use of a medication called lacosamide in children with epilepsy. Epilepsy is a condition that affects the brain and causes repeated seizures. The medication being tested, lacosamide, is given in the form of a syrup and is taken orally. The purpose of this study is to learn if lacosamide is safe to take over a long period of time for children who have already participated in previous studies involving this medication.

Participants in this study will continue to take lacosamide syrup, with doses ranging from 2 milligrams per kilogram of body weight per day to 12 milligrams per kilogram per day. The study will monitor the participants over time to observe any side effects or adverse events that may occur while taking the medication. The study aims to ensure that the medication is safe and to determine the most suitable daily dose for long-term use.

The study is designed to follow participants who have completed earlier studies, ensuring they continue to receive treatment and monitoring. The researchers will collect information on any side effects, changes in health, and the overall effectiveness of the medication in managing epilepsy symptoms. This information will help in understanding the long-term safety and benefits of using lacosamide in children with epilepsy.

1 joining the study

Upon joining the study, you will be asked to confirm that you have completed participation in one of the previous studies, either EP0034 or SP848. This is a requirement to ensure that you are eligible to participate in this follow-up study.

You will also need to provide consent, which means agreeing to participate in the study after understanding all the details and what is expected of you.

2 medication administration

You will be given a medication called lacosamide, which is a syrup taken by mouth. The dosage will be between 2 mg/kg/day and 12 mg/kg/day. The exact dose will be determined by the study team based on your specific needs.

The medication is intended to be taken daily, and the study will monitor how you respond to this treatment over a long period.

3 monitoring and assessments

Throughout the study, you will be regularly monitored to assess your response to the medication. This includes checking for any side effects or adverse reactions, which are called treatment-emergent adverse events (TEAEs).

The study team will also track the daily dose you are taking and any changes in your condition.

4 completion of the study

The study is expected to continue until August 31, 2025. During this time, you will continue to take the medication and attend regular check-ups as scheduled by the study team.

At the end of the study, your overall health and response to the medication will be evaluated to determine the long-term safety and effectiveness of lacosamide for treating epilepsy.

Who Can Join the Study?

The participant can be a boy or girl.
The participant must be younger than 6 years old at the time of signing the consent form.
The participant must have completed participation in one of the previous studies: NCT01964560 (EP0034) or NCT00938912 (SP848).
The participant is expected to benefit from participation, according to the study doctor.

Who Cannot Join the Study?

Patients who have not completed the previous studies identified as NCT01964560 or NCT00938912 cannot participate.
Patients who are not within the age range specified for the study.
Patients who are not diagnosed with epilepsy.
Patients who are not able to take the medication in the form of an oral solution.
Patients who have any other medical condition that might interfere with the study.
Patients who are not able to follow the study procedures or instructions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi	Iasi	Romania
Semmelweis University	Budapest	Hungary
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara	Timisoara	Romania
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaza	Budapest	Hungary
Centrul National Clinic De Recuperare Neuropsihomotorie Copii Dr. Nicolae Robanescu	Bucharest	Romania

Trial status

Country	Status	Recruitment Start
Hungary	Not recruiting	28.12.2020
Romania	Not recruiting	28.12.2020

Trial locations

Investigated drugs:

Lacosamide

Lacosamide is a medication used in this clinical trial to help manage epilepsy in children. It is taken by mouth as a solution. The main goal of using lacosamide in this study is to see how well it works and how safe it is for long-term use in children who have already been treated with it in previous studies. Lacosamide helps to control seizures by affecting the way electrical signals in the brain are transmitted, which can help reduce the frequency and severity of seizures in people with epilepsy.

Investigated diseases:

Epilepsy

Epilepsy – Epilepsy is a neurological disorder characterized by recurrent, unprovoked seizures. These seizures are episodes of disturbed brain activity that can cause changes in attention or behavior. The condition can affect people of all ages and may vary in severity and frequency. Seizures can manifest as brief lapses of attention, muscle spasms, or convulsions. The progression of epilepsy can involve changes in seizure patterns over time. It is a chronic condition that requires ongoing management.

Trial ID:

2022-502639-21-00

Protocol code:

EP0151

NCT ID:

NCT03559673

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Long-Term Safety Study of Lacosamide for Children with Epilepsy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?