Sunwoo Jun-Sang, Cho Yong Won, Shin Won Chul, Byun Jung-Ick, Shin Jung-Won, Jung Ki-Young
Department of Neurology, Kangbuk Samsung Hospital, Seoul, Korea.
Department of Neurology, Keimyung University School of Medicine, Daegu, Korea.
J Clin Neurol. 2025 Jul;21(4):325-331. doi: 10.3988/jcn.2025.0092.
To evaluate the clinical efficacy and safety of pregabalin in Korean adults with restless legs syndrome (RLS).
In this randomized, multicenter, double-blind, placebo-controlled trial, 78 patients with RLS with an International Restless Legs Scale (IRLS) score ≥15 were randomized 1:1 to receive either pregabalin (=39) or placebo (=39) for 12 weeks. The primary efficacy outcome was the change in the IRLS score, and the secondary outcomes included the Clinical Global Impression-Improvement scale and changes in scores on other RLS symptom questionnaires. Safety was assessed by monitoring treatment-emergent adverse events (TEAE). This study was registered at ClinicalTrials.gov (NCT04161027).
At baseline, the mean IRLS scores were 23.2±5.8 in the pregabalin and 24.5±5.2 in the placebo group (=0.297). After 12 weeks, the baseline-adjusted change in the IRLS score was -6.8 (95% confidence interval [CI] -9.3 to -4.3) in the pregabalin group and -5.4 (95% CI -7.9 to -2.8) in the placebo group, with no significant difference between the groups (=0.420). The secondary efficacy outcomes did not differ between the two groups. The incidence of TEAE was similar between the two groups (48.7% vs. 51.3%, =0.821), with dizziness being the most common TEAE.
This study failed to demonstrate the therapeutic effect of pregabalin compared with placebo for RLS in Korean adults. Possible reasons for the negative results include low dose, insufficient sample size, and substantial placebo response. Further investigations are warranted to optimize pregabalin therapy in Korean adults with RLS.
评估普瑞巴林对韩国成年不宁腿综合征（RLS）患者的临床疗效及安全性。
在这项随机、多中心、双盲、安慰剂对照试验中，78例国际不宁腿量表（IRLS）评分≥15分的RLS患者按1:1随机分组，接受普瑞巴林（n = 39）或安慰剂（n = 39）治疗12周。主要疗效指标为IRLS评分变化，次要指标包括临床总体印象改善量表及其他RLS症状问卷评分的变化。通过监测治疗中出现的不良事件（TEAE）评估安全性。本研究已在ClinicalTrials.gov注册（NCT04161027）。
基线时，普瑞巴林组的平均IRLS评分为23.2±5.8，安慰剂组为24.5±5.2（P = 0.297）。12周后，普瑞巴林组经基线调整后的IRLS评分变化为-6.8（95%置信区间[CI] -9.3至-4.3），安慰剂组为-5.4（95% CI -7.9至-2.8），两组间无显著差异（P = 0.420）。两组的次要疗效指标无差异。两组TEAE的发生率相似（48.7%对51.3%，P = 0.821），头晕是最常见的TEAE。
本研究未能证明在韩国成年RLS患者中，普瑞巴林对比安慰剂有治疗效果。结果为阴性的可能原因包括剂量低、样本量不足以及显著的安慰剂反应。有必要进一步研究以优化韩国成年RLS患者的普瑞巴林治疗方案。
