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首页> 外文期刊>European journal of neurology: the official journal of the European Federation of Neurological Societies >A phase II-III trial of olesoxime in subjects with amyotrophic lateral sclerosis
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A phase II-III trial of olesoxime in subjects with amyotrophic lateral sclerosis

机译：具有肌营养侧面硬化症的受试者olesoxime的II-III期试验

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Background and purpose: To assess the efficacy and safety of olesoxime, a molecule with neuroprotective properties, in patients with amyotrophic lateral sclerosis (ALS) treated with riluzole. Methods: A double-blind, randomized, placebo-controlled, multicenter trial of 18 months' duration was conducted in 512 subjects, with probable or definite ALS and a slow vital capacity (SVC) ≥70%, receiving 330 mg olesoxime daily or matching placebo and 50 mg riluzole twice a day in all. The primary intention-to-treat (ITT) outcome analysis was 18 months' survival. Secondary outcomes were rates of deterioration of the revised ALS functional rating scale (ALSFRS-R), focusing on the 9-month assessment, SVC and manual muscle testing. Blood levels, safety and tolerability of olesoxime were also assessed. Results: At 18 months, 154 of the 512 ITT patients had died (79 of 253 placebo, 75 of 259 olesoxime). Estimated overall survival according to Kaplan-Meier analysis was 67.5% (95% CI 61.0%-73.1%) in the placebo group and 69.4% (95% CI 63.0%-74.9%) in the olesoxime group; hence survival was not significantly different between treatment arms (P = 0.71, stratified bulbar/spinal log-rank). The other efficacy end-points evaluated were also negative, with the exception of a small difference in ALSFRS-R global score at 9 months in favor of olesoxime but not sustained after 18 months' treatment nor evident in either the stratified bulbar or spinal subpopulations. Treatment did not raise any safety concerns. Conclusions: Olesoxime, although well tolerated, did not show a significant beneficial effect in ALS patients treated with riluzole.
机译：背景和目的：评估用瑞洛唑处理的肌营养的外侧硬化症（ALS）患者olesoxime的疗效和安全性，具有神经保护性的分子。方法：在512个受试者中进行双盲，随机，安慰剂控制，18个月持续时间的多中心试验，有可能的或明确的ALS和慢速容量（SVC）≥70％，每天接受330毫克Olesoxime或匹配安慰剂和50毫克里尔鲁唑每天两次。主要意向治疗（ITT）结果分析为18个月的存活率。二次结果是修订的ALS功能评级规模（ALSFRS-R）恶化的率，重点关注9个月的评估，SVC和手动肌肉测试。还评估了Olesoxime的血液水平，安全性和耐受性。结果：18个月，512号ITT患者的154名患者（共253名排名79，共259名Olesoxime）。根据KAPLAN-MEIER分析的估计总生存率为安慰剂组的67.5％（95％CI 61.0％-73.1％），Olesoxime组中的69.4％（95％CI 63.0％-74.9％）;因此，治疗臂之间的存活率没有显着差异（p = 0.71，分层泡杆/脊柱对数）。评估的其他疗效终点也是阴性的，除了在9个月的ALSFRS-R全球分数差异，有利于Olesoxime，但在18个月的治疗后不持续，也不在分层的凸形群或脊髓群中明显。治疗没有提出任何安全问题。结论：Olesoxime，虽然耐受性良好，但在用瑞洛唑治疗的ALS患者中没有表现出显着的有益效果。

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