This study is trialing a novel anti-epileptic medication called XEN1101 in patients who suffer from primary generalized tonic-clonic seizures and have not achieved satisfactory seizure control using standard therapies.
The study evaluates the safety and effectiveness of XEN1101, an oral drug, aimed at reducing the frequency of seizure. 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
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Trial status
Recruiting
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Trial phase
Phase 3 Drug TrialLate stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
- Registry listing
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ERM Project ID
94759
Trial contact details
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Contact person
Delphine Lévy-Bencheton
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 generalised epilepsy with probable or possible primary generalized tonic-clonic seizures (also known as grand mal seizures)
• First began having seizures before age 40 years
• Have tried two or more anti-epileptic medications but did not achieve sustained freedom from seizures
People with certain medical conditions or taking some 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 eligibility criteria with you if you are interested in taking part.
What is involved for you?
Study participants will be randomly assigned to receive 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
