Weiss Daniel, Jost Wolfgang H, Szász József Attila, Pirtošek Zvezdan, Milanov Ivan, Tomantschger Volker, Kovács Norbert, Staines Harry, Amlani Bharat, Smith Niall, van Laar Teus
Department for Neurodegenerative Diseases, Centre for Neurology, Hertie-Institute for Clinical Brain Research, Tübingen, Germany.
Parkinson-Klinik Ortenau, Wolfach, Germany.
Mov Disord Clin Pract. 2025 Aug;12(8):1075-1085. doi: 10.1002/mdc3.70046. Epub 2025 Mar 25.
Levodopa-entacapone-carbidopa intestinal gel (LECIG) was introduced in 2018 as a device-aided therapy for advanced Parkinson's disease (PD).
The ELEGANCE study (NCT05043103) is gathering real-world data on long-term efficacy, safety and patient-reported outcomes with LECIG from 13 European countries. This article reports data from the planned interim analysis.
The study enrolled patients prescribed LECIG as part of routine clinical care. We evaluated patients at V1 before starting LECIG treatment (in seven patients V1 data were obtained retrospectively), and thereafter at V2 (3-6 months) or V3 (6-12 months).
This analysis includes 167 patients from 37 centers. Three patients from this analysis set (1.8%) discontinued the study. Mean (±SD) daily OFF-time hours (MDS-UPDRS IV item 4.3) were substantially reduced by 3.47 ± 3.56 h at V2 (baseline: 5.15 ± 3.05; P < 0.0001). Similarly, MDS-UPDRS part IV total scores were reduced by 4.24 ± 4.08 at V2 (baseline: 10.77 ± 3.83); (P = 0.0001) and MDS-UPDRS part II scores by 3.63 ± 7.76 at V2 (baseline: 20.65 ± 8.17; P = 0.0004). PDSS-2 total scores were sustainably improved (reduction of 7.38 ± 10.72 at V2 [baseline: 25.21 ± 10.62]; P < 0.0001), as was the PDQ-8 summary index score indicating an improvement in quality of life (QoL) (reduction of 13.3 ± 19.05 at V2 [baseline: 46.34 ± 20.09]; P < 0.0001). For all parameters improvements were maintained at V3. Patient-reported satisfaction with the LECIG pump was high. Most adverse events were related to the procedure or the device.
Routine use of LECIG for up to 12 months provided sustained control of motor symptoms, and was well tolerated with a positive impact on QoL and high patient satisfaction.
左旋多巴-恩他卡朋-卡比多巴肠凝胶（LECIG）于2018年作为一种用于晚期帕金森病（PD）的器械辅助疗法推出。
ELEGANCE研究（NCT05043103）正在收集来自13个欧洲国家的关于LECIG的长期疗效、安全性和患者报告结局的真实世界数据。本文报告了计划中的中期分析数据。
该研究纳入了作为常规临床护理一部分而开具LECIG处方的患者。我们在开始LECIG治疗前的V1评估患者（7例患者的V1数据是回顾性获得的），此后在V2（3 - 6个月）或V3（6 - 12个月）进行评估。
该分析包括来自37个中心的167例患者。该分析集中有3例患者（1.8%）退出研究。V2时平均（±标准差）每日关期时长（MDS-UPDRS IV项目4.3）大幅减少3.47±3.56小时（基线：5.15±3.05；P<0.0001）。同样，V2时MDS-UPDRS第四部分总分减少4.24±4.08（基线：10.77±3.83）；（P = 0.0001），V2时MDS-UPDRS第二部分得分减少3.63±7.76（基线：20.65±8.17；P = 0.0004）。PDSS-2总分持续改善（V2时减少7.38±10.72[基线：25.21±10.62]；P<0.0001），表明生活质量（QoL）改善的PDQ-8综合指数得分也是如此（V2时减少13.3±19.05[基线：46.34±20.09]；P<0.0001）。对于所有参数，在V3时改善得以维持。患者对LECIG泵的报告满意度较高。大多数不良事件与操作或器械有关。
LECIG常规使用长达12个月可提供对运动症状的持续控制，耐受性良好，对QoL有积极影响且患者满意度高。
