Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

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

This study is a long-term follow-up to understand the effects of a medicine called lacosamide for people living with epilepsy. It's designed for individuals who have already participated in earlier studies (named EP0034 or SP848) and were treated with lacosamide. The main goal is to check for any side effects that might appear over a longer period and to see how well people tolerate the medicine. Researchers will also look at how many people stop the study due to side effects and the typical and highest doses of lacosamide used. This helps doctors know more about the ongoing safety and use of this treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

UCB Biopharma

Enrolment target

Start

27 Mar 2023

Epilepsy

What is this study about?

This study is a follow-up for people who have epilepsy and have previously been part of other studies testing a medicine called lacosamide. Think of it like this: after a doctor tries a new medicine for a short time, they also need to see what happens when people take it for much longer.

The main purpose of this study is to keep a close eye on the ongoing safety of lacosamide. Researchers want to know about any side effects that might occur over a long period, especially those that might be serious. They'll also record if anyone needs to stop taking the medicine because of side effects. This longer-term information is really important for doctors to fully understand how lacosamide affects people with epilepsy.

Beyond safety, the study will also look at the typical and highest daily doses of lacosamide that people take. This helps doctors and researchers understand the most effective and safest ways to use this medicine for epilepsy in the long run. By gathering this detailed information from many people, researchers can provide better guidance for future epilepsy treatments.

Key takeaways

This study focuses on the long-term safety of lacosamide for epilepsy.
It's for people who have already used lacosamide in earlier research studies.
The main aim is to track any side effects and how people tolerate the medicine.
Participants will continue their current lacosamide treatment under close medical supervision.

Who may be eligible?

This study is for anyone who has epilepsy and has already taken part in specific earlier studies where they received lacosamide treatment. It doesn't matter how old you are, whether you're a man or a woman, or any other personal characteristic. The main thing is that you've already had experience with lacosamide in one of those previous trials.

If you completed another study called EP0034 or SP848 and were given lacosamide as part of that study, then you might be able to join this long-term follow-up. The research team will review your medical history from those earlier studies to make sure this study is right for you and safe for your health.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have epilepsy?
Did I participate in study EP0034 or SP848?
Did I receive lacosamide treatment in one of those previous studies?
Am I willing to continue taking lacosamide under medical supervision?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would continue to receive lacosamide, the same medication you were taking in the previous study. The main focus will be on monitoring your health closely. This means you would have regular visits to the clinic, where doctors and nurses would check for any side effects and see how you are doing overall. They will carefully record any health changes or concerns you have.

During these visits, you might have some simple tests, like blood pressure checks, and answer questions about your health and how you're feeling. They will also keep track of the dose of lacosamide you are taking. The study is designed to follow you for a longer period to understand the long-term effects of the medicine, but the exact total duration will be discussed with you by the study team.

Potential risks and benefits

A potential benefit of joining this study is that you would continue to receive lacosamide treatment for your epilepsy while being closely monitored by a medical team. This close monitoring means any potential side effects would likely be identified and managed quickly. As with any medication, there are always potential risks, including side effects from lacosamide, which will be discussed in detail by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary
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Unverified
Romania

Common questions

What is the main goal of this study?

The main goal is to understand the long-term safety of lacosamide and how well it's tolerated by people with epilepsy who have already taken it in previous studies.

Who can join this study?

Anyone who has epilepsy and previously completed one of two specific studies (EP0034 or SP848) where they received lacosamide treatment.

Will I take a new medicine in this study?

No, you will continue to take lacosamide, the same medicine you were given in the previous study.

What will I have to do if I join?

You'll have regular visits to the clinic for health checks, to monitor for side effects, and to discuss your progress with the study team.

How long will I be in the study?

This is a long-term follow-up, so you'll be monitored over an extended period. The exact duration will be explained by the study team.