{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,19]],"date-time":"2026-07-19T01:02:01Z","timestamp":1784422921086,"version":"3.55.0"},"reference-count":39,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2023,10,26]],"date-time":"2023-10-26T00:00:00Z","timestamp":1698278400000},"content-version":"unspecified","delay-in-days":25,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["GNT2023250"],"award-info":[{"award-number":["GNT2023250"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["RFRHPSI000008"],"award-info":[{"award-number":["RFRHPSI000008"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,9,27]]},"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>This randomised placebo-controlled trial aims to evaluate the antiseizure and disease-modifying effects of sodium selenate in people with drug-resistant TLE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This will be a randomised placebo-controlled trial of sodium selenate. One hundred and twenty-four adults with drug-resistant TLE and \u22654 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\u2009mg three times a day, increasing to 15\u2009mg three times a day at week 4 if tolerated) or a matching placebo for 26 weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcomes<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study will be the first disease-modification randomised controlled trial in patients with drug-resistant TLE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ANZCTR; ACTRN12623000446662.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-075888","type":"journal-article","created":{"date-parts":[[2023,10,27]],"date-time":"2023-10-27T09:35:10Z","timestamp":1698399310000},"page":"e075888","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["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"],"prefix":"10.1136","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1182-0907","authenticated-orcid":false,"given":"Lucy","family":"Vivash","sequence":"first","affiliation":[{"name":"Department of Neuroscience, Monash University, Melbourne, Victoria, Australia"},{"name":"Department of Neurology, Alfred Health, Melbourne, Victoria, Australia"},{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Department of Neurology, The Royal Melbourne Hospital, Parkville, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Johns","sequence":"additional","affiliation":[{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonid","family":"Churilov","sequence":"additional","affiliation":[{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"MacPhail","sequence":"additional","affiliation":[{"name":"Department of Neuroscience, Monash University, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pablo","family":"Casillas-Espinosa","sequence":"additional","affiliation":[{"name":"Department of Neuroscience, Monash University, Melbourne, Victoria, Australia"},{"name":"Department of Neurology, Alfred Health, Melbourne, Victoria, Australia"},{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Department of Neurology, The Royal Melbourne Hospital, Parkville, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Malpas","sequence":"additional","affiliation":[{"name":"Department of Neuroscience, Monash University, Melbourne, Victoria, Australia"},{"name":"Department of Neurology, Alfred Health, Melbourne, Victoria, Australia"},{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Department of Neurology, The Royal Melbourne Hospital, Parkville, Victoria, Australia"},{"name":"Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandy R","family":"Shultz","sequence":"additional","affiliation":[{"name":"Department of Neuroscience, Monash University, Melbourne, Victoria, Australia"},{"name":"Department of Neurology, Alfred Health, Melbourne, Victoria, Australia"},{"name":"Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Department of Health Sciences, Vancouver Island University, Vancouver, British Columbia, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Tailby","sequence":"additional","affiliation":[{"name":"Florey Institute of Neuroscience and Mental Health - 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