Kataoka Hiroshi, Isogawa Masahiro, Nanaura Hitoki, Kurakami Hiroyuki, Hasebe Miyoko, Kinugawa Kaoru, Kiriyama Takao, Izumi Tesseki, Kasahara Masato, Sugie Kazuma
Department of Neurology, Nara Medical University, Kashihara, Nara, Japan.
Institute for Clinical and Translational Science, Nara Medical University Hospital, Kashihara, Nara, Japan.
Clin Park Relat Disord. 2024 Nov 22;11:100285. doi: 10.1016/j.prdoa.2024.100285. eCollection 2024.
Zonisamide is a medication developed in Japan that is effective for motor symptoms and wearing off in Parkinson's disease (PD). Zonisamide has properties that may improve sleep disorders. The aim of this study is to verify the safety and efficacy of zonisamide for sleep disorders and rapid eye movement (REM) sleep behavioral disorders (RBD) using a mobile two-channel electroencephalography /electrooculography recording system in patients with PD.
The present study is a single-blind randomized placebo-controlled trial. The subjects in the treatment group took zonisamide (25 mg per day) before bedtime. The primary outcome was sleep efficiency. The secondary endpoints were assessed as followed; objective outcomes of TST WASO, SOL, REM sleep/non-REM sleep ratio, deep sleep (N3) time, ratio of RWA to total REM sleep epochs, and subjective outcomes of the PDSS-2, Pittsburgh sleep questionnaire, and RBDSQ.
Between the zonisamide and placebo groups, no significant differences were found in the primary outcome and secondary outcomes.
The objective and subjective sleep metrics in this clinical trial did not significantly demonstrate zonisamide efficacy for sleep disorder in patients with PD. Although not significant, improvement in WASO and SOL was observed when zonisamide was compared with the placebo.
唑尼沙胺是一种在日本研发的药物，对帕金森病（PD）的运动症状和剂末现象有效。唑尼沙胺具有可能改善睡眠障碍的特性。本研究的目的是使用移动双通道脑电图/眼动图记录系统，验证唑尼沙胺对PD患者睡眠障碍和快速眼动（REM）睡眠行为障碍（RBD）的安全性和有效性。
本研究是一项单盲随机安慰剂对照试验。治疗组的受试者在睡前服用唑尼沙胺（每日25毫克）。主要结局指标为睡眠效率。次要终点按以下方式评估；TST、WASO、SOL、REM睡眠/非REM睡眠比率、深睡眠（N3）时间的客观结局指标，以及RWA占总REM睡眠时段的比率，以及PDSS-2、匹兹堡睡眠问卷和RBDSQ的主观结局指标。
在唑尼沙胺组和安慰剂组之间，主要结局指标和次要结局指标均未发现显著差异。
在这项临床试验中，客观和主观睡眠指标均未显著证明唑尼沙胺对PD患者睡眠障碍有效。虽然差异不显著，但与安慰剂相比，唑尼沙胺组的WASO和SOL有所改善。
