A disease modification drug for Temporal Lobe Epilepsy
The study will investigate a new drug, sodium selenate, for the treatment of chronic drug resistant temporal lobe epilepsy (TLE). The study will compare sodium selenate to placebo to see if treatment with sodium selenate improves clinical outcomes in patients with chronic TLE. 124 patients with chronic temporal lobe epilepsy will be recruited from specialist centres in Melbourne, Brisbane, Sydney, and Perth. Half will receive sodium selenate and the other half will receive placebo. Neither the patients, their families or the doctors will know whether they are taking sodium selenate or placebo.
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 a diagnosis of drug resistant Temporal Lobe Epilepsy (>2 years)
• have ≥4 countable seizures per month
People with certain medical conditions or taking some medications may not be eligible 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 me?
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 26 weeks. 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. All participants will have the opportunity to receive the investigational medication after completion of the trial (52 weeks), independently of their group of origin (placebo versus study drug)
Participants will also undertake the following procedures, tests and assessments:
- Physical exam and medical history
- Neurological exams
- 24hrs EEG (ambulatory)
- Health and wellbeing questionnaires
- Reasoning and thinking assessments
- Electrocardiograms (ECG)
- Pregnancy tests if applicable
- Blood tests
- Urine tests
- Keep a seizure diary
