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Study on the Effectiveness and Safety of Levetiracetam XR for Patients with Drug-Resistant Partial Onset Epilepsy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Refractory Partial Onset Epilepsy, which is a type of epilepsy where seizures start in one part of the brain and are resistant to treatment. The study aims to evaluate the effectiveness and safety of a medication called Levetiracetam XR, which is an extended-release form of levetiracetam, used as an additional therapy for patients who have not responded well to other treatments. The trial will compare this extended-release form to the immediate-release form of levetiracetam, known as Keppra, as well as a placebo.

The purpose of the study is to see if Levetiracetam XR can reduce the frequency of seizures in patients with drug-resistant focal onset seizures. Participants in the study will receive either the extended-release levetiracetam, the immediate-release levetiracetam, or a placebo. The study will last for a total of 12 weeks, during which the participants will take the medication once daily. Throughout the study, the frequency of seizures will be monitored to assess any changes or improvements.

Participants will be asked to keep a diary of their seizures and any side effects they experience. The study will also look at how the treatment affects the participants' quality of life and their satisfaction with the medication. The goal is to find out if Levetiracetam XR can offer a better treatment option for those with difficult-to-treat epilepsy, potentially leading to fewer seizures and an improved quality of life.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the diagnosis of epilepsy with focal-onset seizures and ensuring stable doses of anti-seizure medication for at least four weeks prior to the study.

  2. Step 2

    Baseline observation

    A baseline observation period of eight weeks is required to document seizure frequency. During this time, at least six seizures must be recorded to confirm drug-resistant focal-onset seizures.

  3. Step 3

    Randomization and treatment allocation

    Participants are randomly assigned to receive either Levetiracetam XR, Keppra 500 mg film-coated tablets, or a placebo. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being administered.

  4. Step 4

    Treatment phase

    The treatment phase lasts for 12 weeks. Participants take the assigned medication once daily. The goal is to assess the reduction in weekly focal-onset seizure frequency compared to baseline.

  5. Step 5

    Monitoring and data collection

    Throughout the treatment phase, participants are required to maintain a diary to record seizure activity and any side effects. Regular check-ins are scheduled to monitor progress and ensure compliance with the study protocol.

  6. Step 6

    End of treatment evaluation

    At the end of the 12-week treatment period, a final evaluation is conducted. This includes assessing changes in seizure frequency, quality of life, and overall satisfaction with the treatment.

Who can join the trial?

9 criteria

  • Participants must be male or female, aged between 12 and 80 years for Spain, Poland, and Bulgaria. In other countries, only adults are included.
  • Participants must be willing and able to provide an informed consent form, follow study procedures like completing an electronic diary, and take their regular anti-seizure medication and the study medication as instructed.
  • Participants must have a diagnosis of epilepsy with Focal-onset seizures (FOS), which are seizures that start in one area of the brain, with or without spreading to other areas.
  • Participants must be on stable doses of anti-seizure medication for at least 4 weeks before the study begins.
  • Participants must have drug-resistant FOS, meaning their seizures do not respond to 1-3 stable anti-seizure medications, and they must have had at least 6 seizures during an 8-week observation period.
  • If participants have a Vagal Nerve Stimulator (VNS), a device used to help control seizures, it must have stable settings for more than 3 months before the study and should not change during the study.
  • Females who can have children must use a highly effective form of birth control if they are not abstinent, starting 60 days before the study and continuing for 30 days after the study medication ends. This includes methods like hormonal contraception, intrauterine devices, or having a partner who has had a vasectomy.
  • Females who cannot have children must be surgically sterilized, have had a hysterectomy, or be at least 1 year past menopause.
  • Sexually active males with partners who can have children must agree to use an acceptable method of birth control consistently and correctly for 90 days after the last study medication is taken.

Who cannot join the trial?

5 criteria

  • Patients who do not have **Refractory Partial Onset Epilepsy** cannot participate. This means if your epilepsy is not resistant to treatment, you are not eligible.
  • Patients who are not experiencing **Focal Onset Seizures (FOS)**, which are seizures that start in one area of the brain, are excluded.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, so if you are outside these groups, you are not eligible.
  • Both **male and female** patients are eligible, so gender is not a reason for exclusion.
  • Patients who are part of a **vulnerable population** may be excluded. This refers to groups who might need special protection in research, like children or those unable to give consent.
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Investigated drugs

  • Levetiracetam Extended Release (XR)

    is a medication used in this study as an add-on therapy for patients with epilepsy who experience partial onset seizures that are resistant to other treatments. The extended release form is designed to be taken once daily, allowing the medication to be released slowly over time to help control seizures more effectively throughout the day.

  • Levetiracetam Immediate Release (IR)

    is another form of the same medication used in the study for comparison. This version is released into the body more quickly and may require more frequent dosing. It is used to help manage seizures in patients with epilepsy, and the study aims to compare its effectiveness and safety to the extended release version.

What is already known about the treatment

Levetiracetam – This medication is administered orally in the form of extended-release tablets. It is currently being studied in clinical trials for its effectiveness and safety as an add-on therapy for patients with refractory partial onset epilepsy. The main therapeutic indication is to reduce the frequency of focal onset seizures in individuals who do not respond well to other treatments. At the molecular level, levetiracetam works by modulating neurotransmitter release through binding to a specific protein in the brain, which helps stabilize electrical activity. It is classified as an antiepileptic drug.

Investigated diseases

Refractory Partial Onset Epilepsy – This is a type of epilepsy where seizures begin in a specific part of the brain and are resistant to treatment with standard anti-seizure medications. These seizures, known as focal onset seizures, can affect various functions depending on the brain area involved, such as movement, sensation, or consciousness. The condition is characterized by frequent and unpredictable seizures that can vary in intensity and duration. Over time, the persistence of these seizures can impact daily activities and quality of life. Despite medication, individuals with this condition continue to experience seizures, making management challenging. The focus is often on reducing seizure frequency and improving the individual's overall well-being.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514499-42-00Protocol codeNXPLEVE/24/P3-6Estimated enrolment213 patientsSponsorNeuraxpharm Pharmaceuticals S.L.

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