Phase II randomised placebo-controlled trial of sodium selenate as a disease-modifying treatment in chronic drug-resistant temporal lobe epilepsy: the SeLECT study protocol
Lucy Vivash,
Dennis Velakoulis,
Patrick Carney,
Patrick Kwan,
Leonid Churilov,
Terence J O’Brien,
Christopher M Hovens,
Nicholas Lawn,
Piero Perucca,
Sandy R Shultz,
John-Paul Nicolo,
Charles Malpas,
Manori Wijayath,
David Reutens,
Hannah Johns,
Sara MacPhail,
Pablo Casillas-Espinosa,
Chris Tailby,
Lisa Gillinder
Affiliations
Lucy Vivash
Monash University Central Clinical School, Melbourne, Victoria, Australia
Dennis Velakoulis
15Melbourne Neuropsychiatry Centre, North West Mental Health and The University of Melbourne, Melbourne, Australia
Patrick Carney
Bladin-Berkovic Comprehensive Epilepsy Program, Department of Neurology, Austin Health, Heidelberg, texas, Australia
Patrick Kwan
Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Victoria, Australia
Leonid Churilov
7 Medicine, The University of Melbourne, Melbourne, Victoria, Australia
Terence J O’Brien
Monash University Central Clinical School, Melbourne, Victoria, Australia
Christopher M Hovens
Department of Surgery, Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia
Nicholas Lawn
1 Neurology, WA Adult Epilepsy Service, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia
Piero Perucca
1Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia
Sandy R Shultz
Department of Neuroscience, Monash University, Melbourne, Victoria, Australia
John-Paul Nicolo
1 Department of Neurology, Alfred Health, Prahran, Victoria, Australia
Charles Malpas
1 Department of Neuroscience, School of Translational Medicine, Monash University, Melbourne, Victoria, Australia
Manori Wijayath
Nepean Hospital, Kingswood, NSW, Australia
David Reutens
6The Epilepsy Program, Royal Brisbane and Women’s Hospital, The University of Queensland, Brisbane, QLD, Australia
Hannah Johns
3University of Melbourne, Melbourne, VIC
Sara MacPhail
Department of Neuroscience, Monash University, Melbourne, Victoria, Australia
Pablo Casillas-Espinosa
Department of Neuroscience, Monash University, Melbourne, Victoria, Australia
Chris Tailby
3Department of Neuropsychology, Austin Health, Heidelberg, VIC, Australia
Lisa Gillinder
5Department of Neurology, Mater Hospital Brisbane, Brisbane, Queensland, Australia
Introduction Epilepsy is one of the most common neurological conditions worldwide. Despite many antiseizure medications (ASMs) being available, up to one-third of patients do not achieve seizure control. Preclinical studies have shown treatment with sodium selenate to have a disease-modifying effect in a rat model of chronic temporal lobe epilepsy (TLE).Aim This randomised placebo-controlled trial aims to evaluate the antiseizure and disease-modifying effects of sodium selenate in people with drug-resistant TLE.Methods This will be a randomised placebo-controlled trial of sodium selenate. One hundred and twenty-four adults with drug-resistant TLE and ≥4 countable seizures/month will be recruited. Outcomes of interest will be measured at baseline, week 26 and week 52 and include an 8-week seizure diary, 24-hour electroencephalogram and cognitive, neuropsychiatric and quality of life measures. Participants will then be randomised to receive a sustained release formulation of sodium selenate (initially 10 mg three times a day, increasing to 15 mg three times a day at week 4 if tolerated) or a matching placebo for 26 weeks.Outcomes The primary outcome will be a consumer codesigned epilepsy-Desirability of Outcome Rank (DOOR), combining change in seizure frequency, adverse events, quality of life and ASM burden measures into a single outcome measure, compared between treatment arms over the whole 52-week period. Secondary outcomes will compare baseline measures to week 26 (antiseizure) and week 52 (disease modification). Exploratory measures will include biomarkers of treatment response.Ethics and dissemination The study has been approved by the lead site, Alfred Hospital Ethics Committee (594/20). Each participant will provide written informed consent prior to any trial procedures. The results of the study will be presented at national and international conferences, published in peer-reviewed journals and disseminated through consumer organisations.Conclusion This study will be the first disease-modification randomised controlled trial in patients with drug-resistant TLE.Trial registration number ANZCTR; ACTRN12623000446662.
