دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | Vivash L; Department of Neuroscience, Monash University, Melbourne, Victoria, Australia lucy.vivash@monash.edu.; Department of Neurology, Alfred Health, Melbourne, Victoria, Australia.; Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.; Department of Neurology, The Royal Melbourne Hospital, Parkville, Victoria, Australia., Johns H; Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia., Churilov L; Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia., MacPhail S; Department of Neuroscience, Monash University, Melbourne, Victoria, Australia., Casillas-Espinosa P; Department of Neuroscience, Monash University, Melbourne, Victoria, Australia.; Department of Neurology, Alfred Health, Melbourne, Victoria, Australia.; Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.; Department of Neurology, The Royal Melbourne Hospital, Parkville, Victoria, Australia., Malpas C; Department of Neuroscience, Monash University, Melbourne, Victoria, Australia.; Department of Neurology, Alfred Health, Melbourne, Victoria, Australia.; Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.; Department of Neurology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.; Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia., Shultz SR; Department of Neuroscience, Monash University, Melbourne, Victoria, Australia.; Department of Neurology, Alfred Health, Melbourne, Victoria, Australia.; Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.; Department of Health Sciences, Vancouver Island University, Vancouver, British Columbia, Australia., Tailby C; Florey Institute of Neuroscience and Mental Health - Austin Campus, Heidelberg, Victoria, Australia.; Department of Clinical Neuropsychology, Austin Hospital, Heidelberg, Victoria, Australia., Wijayath M; Department of Neurology, Westmead Hospital, Westmead, New South Wales, Australia., Reutens D; Department of Neurology, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.; Centre for Advanced Imaging, University of Queensland, Brisbane, Queensland, Australia., Gillinder L; Epilepsy Unit, Mater Hospital Brisbane, Brisbane, Queensland, Australia.; Mater Research Institute, University of Queensland, Brisbane, Queensland, Australia., Perucca P; Department of Neuroscience, Monash University, Melbourne, Victoria, Australia.; Department of Neurology, Alfred Health, Melbourne, Victoria, Australia.; Department of Neurology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.; Epilepsy Research Centre, Austin Hospital, Heidelberg, Victoria, Australia.; Bladin-Berkovic Comprehensive Epilepsy Program, Department of Neurology, Austin Health, Heidelberg, texas, Australia., Carney P; Bladin-Berkovic Comprehensive Epilepsy Program, Department of Neurology, Austin Health, Heidelberg, texas, Australia.; Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia., Nicolo JP; Department of Neuroscience, Monash University, Melbourne, Victoria, Australia.; Department of Neurology, Alfred Health, Melbourne, Victoria, Australia.; Department of Neurology, The Royal Melbourne Hospital, Parkville, Victoria, Australia., Lawn N; Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia., Kwan P; Department of Neuroscience, Monash University, Melbourne, Victoria, Australia.; Department of Neurology, Alfred Health, Melbourne, Victoria, Australia.; Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.; Department of Neurology, The Royal Melbourne Hospital, Parkville, Victoria, Australia., Velakoulis D; Department of Neuropsychiatry, Royal Melbourne Hospital, Parkville, Victoria, Australia.; Melbourne Neuropsychiatry Centre, University of Melbourne, Parkville, Victoria, Australia., Hovens CM; Department of Surgery, Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia., O'Brien TJ; Department of Neuroscience, Monash University, Melbourne, Victoria, Australia.; Department of Neurology, Alfred Health, Melbourne, Victoria, Australia.; Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.; Department of Neurology, The Royal Melbourne Hospital, Parkville, Victoria, Australia. |
| المصدر: | BMJ open [BMJ Open] 2023 Oct 27; Vol. 13 (10), pp. e075888. Date of Electronic Publication: 2023 Oct 27. |
| نوع المنشور: | Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| مواضيع طبية MeSH: | Epilepsy, Temporal Lobe*/drug therapy , Drug Resistant Epilepsy*/drug therapy, Adult ; Humans ; Animals ; Rats ; Selenic Acid ; Quality of Life ; Treatment Outcome ; Seizures ; Randomized Controlled Trials as Topic ; Clinical Trials, Phase II as Topic |
| مستخلص: | 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. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
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| فهرسة مساهمة: | Keywords: clinical trial; epilepsy; randomized controlled trial |
| سلسلة جزيئية: | ANZCTR ACTRN12623000446662 |
| المشرفين على المادة: | HV0Y51NC4J (Selenic Acid) |
| تواريخ الأحداث: | Date Created: 20231027 Date Completed: 20231030 Latest Revision: 20231103 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC10619053 |
| DOI: | 10.1136/bmjopen-2023-075888 |
| PMID: | 37890967 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2044-6055 |
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| DOI: | 10.1136/bmjopen-2023-075888 |