Department of Neurology C, Expert Parkinson Centre, Hospices Civils de Lyon, Pierre Wertheimer Neurological Hospital, Hôpital Neurologique Pierre Wertheimer, Service de Neurologie C - Hospices Civils de Lyon, NS-Park/F-CRIN, 69677, Bron, France.
Lyon Neuroscience Research Centre, INSERM, University of Lyon, 69622, Lyon, France.
J Neurol. 2023 Oct;270(10):4851-4859. doi: 10.1007/s00415-023-11814-y. Epub 2023 Jun 20.
Impulse control disorders (ICDs) are frequently encountered in Parkinson's disease (PD).
We aimed to assess whether clonidine, an α2-adrenergic receptor agonist, would improve ICDs.
We conducted a multicentre trial in five movement disorder departments. Patients with PD and ICDs (n = 41) were enrolled in an 8-week, randomised (1:1), double-blind, placebo-controlled study of clonidine (75 μg twice a day). Randomisation and allocation to the trial group were carried out by a central computer system. The primary outcome was the change at 8 weeks in symptom severity using the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) score. A reduction of the most elevated subscore of the QUIP-RS of more than 3 points without any increase in the other QUIP-RS dimension defined success.
Between 15 May 2019 and 10 September 2021, 19 patients in the clonidine group and 20 patients in the placebo group were enrolled. The proportion difference of success in reducing QUIP-RS at 8 weeks, was 7% (one-sided upper 90% CI 27%) with 42.1% of success in the clonidine group and 35.0% in the placebo group. Compared to patients in the placebo group, patients in the clonidine group experienced a greater reduction in the total QUIP-RS score at 8 weeks (11.0 points vs. 3.6).
Clonidine was well tolerated but our study was not enough powerful to demonstrate significant superiority compared to placebo in reducing ICDs despite a greater reduction of total QUIP score at 8 weeks. A phase 3 study should be conducted.
The study was registered (NCT03552068) on clinicaltrials.gov on June 11, 2018.
冲动控制障碍（ICD）在帕金森病（PD）中经常发生。
我们旨在评估α2-肾上腺素能受体激动剂可乐定是否能改善 ICD。
我们在五个运动障碍科进行了一项多中心试验。41 名患有 PD 和 ICD（n=41）的患者被纳入为期 8 周的随机（1:1）、双盲、安慰剂对照的可乐定（75μg 每天两次）研究。随机化和分组到试验组由中央计算机系统进行。主要结局是使用帕金森病冲动-强迫障碍评定量表（QUIP-RS）评分在 8 周时症状严重程度的变化。QUIP-RS 中最显著的亚评分降低超过 3 分，而其他 QUIP-RS 维度没有任何增加定义为成功。
在 2019 年 5 月 15 日至 2021 年 9 月 10 日期间，可乐定组有 19 名患者，安慰剂组有 20 名患者入组。8 周时降低 QUIP-RS 的成功率差异为 7%（单侧 90%CI 为 27%），可乐定组成功率为 42.1%，安慰剂组成功率为 35.0%。与安慰剂组相比，可乐定组患者在 8 周时 QUIP-RS 总分降低更大（11.0 分比 3.6 分）。
可乐定耐受良好，但我们的研究没有足够的效力来证明与安慰剂相比在降低 ICD 方面具有显著优势，尽管 8 周时 QUIP 总分降低更大。应该进行一项 3 期研究。
该研究于 2018 年 6 月 11 日在 clinicaltrials.gov 上注册（NCT03552068）。
