Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.
Nephrology, Peking University First Hospital, Beijing, China.
BMJ Open. 2020 Feb 18;10(2):e033815. doi: 10.1136/bmjopen-2019-033815.
Restless legs syndrome (RLS) is a common neurological sensorimotor disorder among patients with end stage renal disease. This clinical trial aimed to provide evidence on the efficacy and safety of pramipexole in patients with uremic RLS receiving peritoneal dialysis (PD).
This is a 12-week, multicentre, randomised, double-blind, placebo-controlled clinical trial. In total, 104 patients with uremic RLS receiving PD will be enrolled from four hospitals and randomly assigned in a 1:1 ratio to either placebo or pramipexole. We will determine the efficacy of pramipexole in the improvement of International RLS Study Group Rating Scale as the primary outcome, while responder rates for other RLS scales at week 12, change from baseline to week 12 for psychological status, sleep disorder and quality of life and blood pressure represent the secondary outcomes.
The study was approved by the ethics committees of Peking University First Hospital, Xinqiao hospital of Army Medical University, Cangzhou Center Hospital and Peking University Shenzhen Hospital. The results will be disseminated in peer-reviewed journals.
NCT03817554.
不宁腿综合征（RLS）是终末期肾病患者中常见的神经感觉运动障碍。本临床试验旨在为接受腹膜透析（PD）的尿毒症 RLS 患者中普拉克索的疗效和安全性提供证据。
这是一项为期 12 周、多中心、随机、双盲、安慰剂对照临床试验。总共将从 4 家医院招募 104 名接受 PD 的尿毒症 RLS 患者，并以 1:1 的比例随机分配至安慰剂或普拉克索组。我们将确定普拉克索在改善国际 RLS 研究组评定量表方面的疗效作为主要结局，而在第 12 周时其他 RLS 量表的应答率、从基线到第 12 周的心理状态、睡眠障碍和生活质量以及血压的变化则代表次要结局。
该研究已获得北京大学第一医院、陆军军医大学新桥医院、沧州市中心医院和北京大学深圳医院的伦理委员会批准。研究结果将在同行评议的期刊上发表。
NCT03817554。
