Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, 3333 Burnet Avenue MLC 4002, Cincinnati, OH, 45229, USA.
Indiana University School of Medicine, Indianapolis, IN, USA.
J Autism Dev Disord. 2018 Sep;48(9):3051-3060. doi: 10.1007/s10803-018-3562-5.
Riluzole is a glutamatergic modulator of particular interest in autism spectrum disorder (ASD). In this 12-week randomized, double-blind, placebo-controlled, crossover pilot study we evaluated the safety and tolerability of 5-week of adjunctive riluzole treatment (vs. 5-week of placebo, with 2-week washout period) targeting ASD-associated drug-refractory irritability in eight individuals age 12-25 years. All participants tolerated riluzole 200 mg per day, however there were no statistically significant findings for the overall treatment effect, the treatment effect by week within period of the study, or a cross-over effect across the periods of the study on the Clinical Global Impression Improvement Scale or the Aberrant Behavior Checklist Irritability subscale. The results of this trial indicate that 5-week of riluzole treatment was well tolerated, but had no significant effect on the target symptoms. Trial Registration ClinicalTrials.gov Identifier NCT02081027, Registered 5 August 2013, First participant enrolled 19 September 2013.
利鲁唑是一种谷氨酸调节剂，在自闭症谱系障碍（ASD）中特别有研究意义。在这项为期 12 周的随机、双盲、安慰剂对照、交叉先导研究中，我们评估了辅助性利鲁唑治疗（与 5 周安慰剂相比，有 2 周洗脱期）在 8 名 12-25 岁患者中的安全性和耐受性，这些患者的 ASD 相关药物难治性易怒。所有参与者都耐受了每天 200 毫克的利鲁唑，但在总体治疗效果、研究期间各周的治疗效果或研究期间各期的交叉效应方面，临床总体印象改善量表或异常行为检查表易激惹分量表上均未发现统计学显著发现。这项试验的结果表明，5 周的利鲁唑治疗耐受性良好，但对目标症状没有显著影响。试验注册ClinicalTrials.gov 标识符 NCT02081027，于 2013 年 8 月 5 日注册，于 2013 年 9 月 19 日首次招募参与者。
