The synthetic tetrahydrocannabinol-analog nabilone improved non-motor symptoms (NMS) in Parkinson’s disease (PD) patients in a placebo-controlled, double-blind, parallel-group, randomized withdrawal trial with enriched enrollment (NMS-Nab-study). This was a single-center open-label extension study to assess the long-term safety and efficacy of nabilone for NMS in PD. To be eligible for this study, patients had to be treatment responders during the previous NMS-Nab-trial and complete its double-blind phase without experiencing a drug-related serious/severe/moderate adverse event (AE). Patients were re-introduced to nabilone during an up-titration phase until their overall NMS burden improved. Nabilone was continued for six months with clinic visits every 3 months. Evaluation of AEs was based on self-report and clinical assessment. Twenty-two patients participated in the NMS-Nab2-study (age-median 68.33 y, 52% females, disease duration-median 7.42 y). Nabilone was well tolerated with concentration difficulties as the most common treatment-related AE (possibly/not related n = 1 each). One in two drop-outs discontinued because of an AE for which a prohibited concomitant medication needed to be introduced (night-time sleep problems). Efficacy evaluation showed a significant and lasting improvement in NMS burden according to the CGI-I (79% at V3). Nabilone improved overall sleep (NMSS Domain-2: –8.26 points; 95%CI –13.82 to –2.71; p = 0.004; ES = –0.72), night-time sleep problems (MDS-UPDRS-1.7: –1.42 points; 95 CI –2.16 to –0.68; p = 0.002; ES = –0.92), and overall pain (KPPS Total Score: –8.00 points; 95%CI –15.05 to –0.95; p = 0.046; ES –0.55 and MDS-UPDRS-1.9: –0.74 points; 95%CI –1.21 to –0.26; p = 0.008; ES = –0.74). This study demonstrates continuous long-term safety and efficacy in PD patients responding early to nabilone without intolerable side effects.

在一项安慰剂对照、双盲、平行组、随机退出试验（NMS-Nab 研究）中，合成四氢大麻酚类似物大麻龙改善了帕金森病 (PD) 患者的非运动症状 (NMS)。这是一项单中心开放标签扩展研究，旨在评估大麻隆治疗 PD 中 NMS 的长期安全性和有效性。为了符合这项研究的资格，患者必须在之前的 NMS-Nab 试验中对治疗有反应，并在完成双盲阶段后没有出现与药物相关的严重/重度/中度不良事件 (AE)。在加量阶段，患者被重新引入大麻隆，直到他们的整体 NMS 负担改善。 Nabilone 持续六个月，每 3 个月就诊一次。 AE 的评估基于自我报告和临床评估。 22 名患者参与了 NMS-Nab2 研究（中位年龄 68.33 岁，52% 为女性，中位病程 7.42 岁）。 Nabilone 的耐受性良好，但浓度困难是最常见的治疗相关 AE（可能/不相关，各n = 1）。两分之一的退出者因出现 AE（需要使用禁用的联合药物）（夜间睡眠问题）而停止治疗。根据 CGI-I（V3 为 79%），功效评估显示 NMS 负担显着且持久的改善。 Nabilone 改善整体睡眠（NMSS Domain-2：–8.26 分；95%CI –13.82 至 –2.71； p = 0.004；ES = –0.72）、夜间睡眠问题（MDS-UPDRS-1.7：–1.42 分；95 CI –2.16 至 –0.68； p = 0.002；ES = –0.92）和总体疼痛（KPPS 总分：–8.00 分；95%CI –15.05 至 –0.95； p = 0.046；ES –0.55 和 MDS-UPDRS- 1.9：–0.74 点；95%CI –1.21 至 –0.26； p = 0。008； ES = –0.74)。这项研究证明了帕金森病患者对大麻龙的早期反应具有持续的长期安全性和有效性，且没有无法忍受的副作用。