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Study on the Effects of Azetukalner in Patients with Focal-Onset Seizures

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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 the effects of a medication called XEN1101 on individuals with focal onset seizures. Focal onset seizures are a type of epilepsy where seizures start in one area of the brain. The medication being tested, XEN1101, is taken in the form of a capsule and is being compared to a placebo to see how well it works in reducing the frequency of these seizures. The main goal of the study is to assess the effect of XEN1101 on reducing the number of seizures experienced by participants.

Participants in the study will be randomly assigned to receive either XEN1101 or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The study will last for a period of 12 weeks, during which participants will take the medication or placebo daily. Throughout the study, participants will be monitored for any changes in their seizure frequency and any side effects they may experience.

The study aims to provide valuable information on the safety and effectiveness of XEN1101 as an additional treatment for people with focal onset seizures. By comparing the results between those taking XEN1101 and those taking the placebo, researchers hope to determine if XEN1101 can significantly reduce the number of seizures and improve the quality of life for individuals with this condition. The findings from this study could potentially lead to new treatment options for people living with focal onset seizures.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide written consent, confirming that you understand the nature and risks of the study.

    You will need to confirm that you have a diagnosis of focal epilepsy and have tried at least two anti-seizure medications without achieving sustained seizure freedom.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet all the criteria for participation. This includes confirming your age, body mass index, and prior neuroimaging results.

    You will be required to maintain a stable dose of 1 to 3 current anti-seizure medications for at least one month before the study begins.

  3. Step 3

    Medication administration

    You will be randomly assigned to receive either the study medication, XEN1101, or a placebo. Both are administered in capsule form for oral use.

    The dosage and frequency of the medication will be determined by the study protocol, and you will be required to take the medication as instructed for the duration of the study.

  4. Step 4

    Ongoing monitoring

    Throughout the study, you will be required to keep accurate seizure diaries to monitor any changes in seizure frequency.

    Regular check-ins will be scheduled to assess your response to the medication and any side effects you may experience.

  5. Step 5

    Completion of study

    At the end of the study period, a final assessment will be conducted to evaluate the effect of the medication on your seizure frequency.

    You will be asked to provide feedback on your experience and any improvements in your condition.

Who can join the trial?

10 criteria

  • The person must be fully informed about the study and its risks and must give written consent to participate.
  • If the person has a device like a vagal nerve stimulator, deep brain stimulator, or responsive neurostimulator, they can join the study if the device has been in place for more than one year and does not need a battery change during the study. The settings of the device must have been stable for more than three months before starting the study and must remain stable throughout the study.
  • The person must be able to participate for the entire duration of the study.
  • The person must have been diagnosed with focal epilepsy for at least two years. Focal epilepsy is a type of epilepsy where seizures start in one area of the brain. The person must have tried at least two anti-seizure medications at proper doses without achieving long-term seizure freedom.
  • The person must be on a stable dose of one to three allowed anti-seizure medications for at least one month before the study starts and throughout the study.
  • The person must be able to keep accurate records of their seizures.
  • The person must be 18 years or older and have a Body Mass Index (BMI) of 40 or less. BMI is a measure of body fat based on height and weight.
  • The person must have had a brain scan, like a CT or MRI, within the last 10 years, and the results must be available.
  • The person must agree to follow the study's rules about birth control.
  • Men must agree not to donate sperm from the start of the study drug until three months after the last dose. Women must agree not to donate eggs from the start of the study drug until six months after the last dose.

Who cannot join the trial?

5 criteria

  • Patients who do not have Focal Onset Seizures cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are not male or female cannot participate.
  • Patients who are considered part of a vulnerable population cannot participate.
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Investigated drugs

XEN1101 is a medication being studied to see if it can help reduce the number of seizures in people who have focal-onset seizures. Focal-onset seizures start in one specific area of the brain and can affect a person's awareness, movement, or feelings. This medication is being tested as an additional treatment, which means it is used along with other seizure medications that a person might already be taking. The goal of the study is to find out if XEN1101 is safe to use, if people can tolerate it well, and if it effectively helps in reducing the frequency of these seizures.

What is already known about the treatment

XEN1101 – XEN1101 is a medication administered orally, designed to help reduce the frequency of focal onset seizures, which are a type of seizure that starts in one area of the brain. Currently, XEN1101 is being studied in a Phase 3 clinical trial to evaluate its safety, tolerability, and effectiveness as an additional treatment for these seizures. The medication works by targeting specific channels in the brain cells, known as potassium channels, to stabilize the electrical activity and prevent seizures. XEN1101 is classified as an anticonvulsant, which is a type of drug used to prevent or reduce the severity of epileptic seizures.

Investigated diseases

Focal Onset Seizures – Focal onset seizures, also known as partial seizures, begin in one specific area of the brain. They can cause a variety of symptoms depending on the brain region affected, such as unusual sensations, movements, or changes in behavior. These seizures may be classified as either aware or impaired awareness, depending on whether consciousness is maintained. As the seizure progresses, it can spread to other parts of the brain, potentially leading to a generalized seizure. The duration of focal onset seizures can vary, typically lasting from a few seconds to a couple of minutes. They can occur sporadically or in clusters, with frequency varying among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502281-25-00Protocol codeXPF-010-302Estimated enrolment324 patientsSponsorXenon Pharmaceuticals Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).