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Study on the Safety and Effectiveness of Azetukalner for Adults with Focal Epilepsy Taking 1 to 3 Anti-Seizure Medications

Fast replyInvestigationalNo placebo

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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 adults with focal epilepsy. Focal epilepsy is a condition where seizures start in one area of the brain. The study aims to evaluate how safe and effective XEN1101 is when used alongside standard treatments for this type of epilepsy. Participants in the study will receive either XEN1101 or a placebo, which is a substance with no active medication, to compare the outcomes.

The study will involve taking the medication in the form of a capsule, which is taken orally. The active ingredient in XEN1101 is called azetukalner. The trial will last for a period of time, during which participants will be monitored for changes in their seizure frequency and any side effects they may experience. The goal is to see if XEN1101 can help reduce the number of seizures and to ensure it is safe for use.

Participants will be required to keep a diary of their seizures and attend regular check-ups to assess their health and the medication's effects. The study includes an open-label extension, meaning that after the initial phase, all participants may have the opportunity to receive XEN1101 if they wish. This trial is an important step in finding new ways to manage focal epilepsy and improve the quality of life for those affected by this condition.

The research process

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

Step 1
Joining the study
Upon joining the study, informed consent is required. This involves understanding the nature and risks of the study and agreeing in writing to participate.
Eligibility is confirmed based on criteria such as age, diagnosis of focal epilepsy, and current treatment with 1 to 3 anti-seizure medications (ASMs).
Step 2
Double-blind phase (DBP)
During this phase, participants receive either the study medication XEN1101 or a placebo. Both are administered in capsule form and taken orally.
The main goal is to assess the effect of XEN1101 on seizure frequency compared to the placebo.
Participants continue their existing ASM treatment while taking the study medication.
Step 3
Medication administration
The study medication, XEN1101, is taken as an additional therapy to the participant's current ASM regimen.
The dosage and frequency are determined by the study protocol and monitored by the study team.
Step 4
Monitoring and assessments
Participants are required to keep accurate seizure diaries to track seizure frequency and any changes.
Regular assessments are conducted to monitor safety, including clinical laboratory tests, ECGs, and evaluations of vital signs.
Step 5
Open-label extension (OLE)
Participants who complete the DBP may enter the OLE phase, where all receive XEN1101.
Eligibility for the OLE includes meeting compliance requirements and not experiencing adverse effects that would preclude participation.
Step 6
Completion of study
The study is expected to conclude by October 31, 2028.
Participants are monitored until the end of the study, with follow-up assessments to ensure safety and efficacy.

Who can join the trial?

9 criteria

Be properly informed about the nature and risks of the study and give written consent before joining.
Be a male or female aged between 18 and 75 years old, with a body mass index (BMI) of 40 or less. BMI is a measure of body fat based on height and weight.
Have been diagnosed with **focal epilepsy** for at least 2 years. Focal epilepsy is a type of epilepsy where seizures start in one area of the brain.
Have had a brain scan (neuroimaging) in the last 10 years, with documentation available.
Be on a stable dose of 1 to 3 allowed anti-seizure medications (ASMs) for at least one month before screening and during the study.
Be willing to follow the contraception requirements as defined in the study protocol.
Males must agree not to donate sperm from the start of the study drug until 6 months after the last dose. Females must agree not to donate eggs (ova) during the same period.
Be able to keep accurate records of seizures in a diary.
Be able to participate for the entire duration of the study.

Who cannot join the trial?

4 criteria

Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
Patients who do not have focal epilepsy cannot participate. Focal epilepsy is a type of epilepsy where seizures start in one specific area of the brain.
Patients who are not currently taking 1 to 3 ASMs cannot participate. ASMs are anti-seizure medications used to help control seizures.
Patients who are part of a vulnerable population may not be eligible. This includes groups who might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Unita Sanitaria Locale Di Bologna
Bologna, Italy
Responsive
Hospital Ruber Internacional
Madrid, Spain
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

Trial locations

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Investigated drugs

XEN1101 is being studied as an additional treatment for adults with focal epilepsy. The trial aims to see how well it works in reducing the frequency of focal seizures when used alongside 1 to 3 other anti-seizure medications. The study also looks at how safe and tolerable XEN1101 is for patients.

Azetukalner

What is already known about the treatment

XEN1101 – XEN1101 is an investigational medication administered orally, currently being studied in clinical trials for its potential use in treating adult focal epilepsy, specifically focal (partial onset) seizures. It is not yet approved for general medical use, but it is being evaluated for its safety, tolerability, and effectiveness as an additional therapy for patients already taking one to three anti-seizure medications. XEN1101 works by modulating potassium channels in the brain, which helps stabilize neuronal activity and reduce seizure frequency. It is classified as an anti-epileptic drug, focusing on enhancing the brain's natural inhibitory mechanisms to control seizures.

Investigated diseases

Adult focal epilepsy – This condition is characterized by seizures that originate in a specific area of the brain. These seizures can affect various functions depending on the brain region involved, such as movement, sensation, or consciousness. The progression of focal epilepsy can vary, with some individuals experiencing frequent seizures while others may have them less often. Seizures may start with an aura, which is a warning sign that a seizure is about to occur. Over time, the pattern and frequency of seizures can change, and they may become more or less severe.