Department of Neuroscience, Monash University, Melbourne, Victoria, Australia
Department of Neurology, Alfred Health, Melbourne, Victoria, Australia.
BMJ Open. 2023 Oct 27;13(10):e075888. doi: 10.1136/bmjopen-2023-075888.
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).
This randomised placebo-controlled trial aims to evaluate the antiseizure and disease-modifying effects of sodium selenate in people with drug-resistant TLE.
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.
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.
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.
This study will be the first disease-modification randomised controlled trial in patients with drug-resistant TLE.
ANZCTR; ACTRN12623000446662.
癫痫是全球最常见的神经系统疾病之一。尽管有许多抗癫痫药物（ASM）可供使用，但多达三分之一的患者无法控制癫痫发作。临床前研究表明，亚硒酸钠治疗在慢性颞叶癫痫（TLE）大鼠模型中具有疾病修饰作用。
本随机安慰剂对照试验旨在评估亚硒酸钠在耐药性 TLE 患者中的抗癫痫和疾病修饰作用。
这将是一项亚硒酸钠的随机安慰剂对照试验。将招募 124 名耐药性 TLE 且每月≥4 次可计数发作的成年人。在基线、第 26 周和第 52 周将测量感兴趣的结果，包括 8 周的癫痫发作日记、24 小时脑电图以及认知、神经心理和生活质量测量。然后，参与者将被随机分配接受缓释形式的亚硒酸钠（最初每天 3 次，每次 10mg，耐受后第 4 周增加至每天 3 次，每次 15mg）或匹配的安慰剂治疗 26 周。
主要结局将是消费者共同设计的癫痫-结局期望排名（DOOR），将发作频率、不良事件、生活质量和 ASM 负担的变化综合到一个单一的结局测量中，在整个 52 周期间比较治疗组之间的差异。次要结局将比较基线与第 26 周（抗癫痫）和第 52 周（疾病修饰）的测量值。探索性措施将包括治疗反应的生物标志物。
该研究已获得主导机构阿尔弗雷德医院伦理委员会（594/20）的批准。在进行任何试验程序之前，每位参与者都将提供书面知情同意书。该研究的结果将在国家和国际会议上报告，发表在同行评议期刊上，并通过消费者组织传播。
这将是第一项针对耐药性 TLE 患者的疾病修饰随机对照试验。
ANZCTR；ACTRN12623000446662。
