X-TOLE2: Clinical trial of a new drug for focal epilepsy

Focal epilepsy is a condition associated with seizures arising from a specific part of the brain. Available anti-epileptic medications and other treatments are able to control seizure activity in the majority of patients. In some patients, however, seizures are not adequately controlled by standard therapies.

This study is trialing a novel anti-epileptic medication called XEN1101 in focal epilepsy patients who have not achieved satisfactory seizure control on at least two anti-epileptic medications.
The study evaluates the safety and effectiveness of XEN1101 for reducing the frequency of seizure. s XEN1101 acts through a different mechanism of action to approved anti-epilepsy drugs, and therefore has potential to control seizures in patients who failed to respond to standard therapies.

Category
Neuroscience
Trial status
Recruiting
Trial phase
Phase 3 Drug Trial
Late stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
Registry listing
NCT05614063
ERM Project ID
94623

Trial contact details

Contact person
Delphine Lévy-Bencheton
Email
d.levybencheton@uq.edu.au

What you need to know

Who can take part?

You may be eligible to participate in this study if you:
•   Are 18 years of age or older
•   Have been diagnosed with focal epilepsy
•   Have tried two or more anti-epileptic medications but did not achieve sustained freedom from seizures

People with certain medical conditions or taking a small number of medications may be ineligible for this study.. People who are considering becoming a mother or father during the study are not eligible to participate. The study staff will discuss the conditions with you if you are interested in taking part. in the study.

What is involved for you?

Study participants will be randomly assigned to receive one of two dose levels of the study drug or placebo in addition to their existing anti-epileptic medications, for a period of 3 months. Neither you, nor the Mater clinical trial team will know whether you are receiving study drug or placebo. This is necessary to provide strong scientific evidence regarding drug effects. Participants who complete the trial will be invited to participate in an “open label” extension study (3 years), in which all participants receive the investigational medication.

Participants will also undertake the following procedures, tests and assessments:
•   Physical exam and medical history
•   Neurological exams
•   Eye exams
•   Health and wellbeing questionnaires
•   Electrocardiograms (ECG)
•   Pregnancy tests if applicable
•   Blood tests
•   Urine tests
•   Keep a seizure diary

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