在帕金森病中长期,持续,皮下注射levodopa/carbidopa输注ND0612:开放标签BeyoND研究的3年结果
Aaron L Ellenbogen1, Werner Poewe2, Alberto J Espay3
1Michigan Institute for Neurological Disorders, Farmington Hills, MI, USA.
Parkinsonism & related disorders
|January 30, 2025
概括
持续的皮下勒沃多巴/卡比多巴输液 (ND0612) 在3年内证明了对帕金森病运动波动的持续安全性和有效性. 高的保留率支持其对患者有利的利益风险概况.
科学领域:
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 帕金森病 (PD) 通常涉及运动波动.
- ND0612是一种正在试验中的连续皮下勒沃多巴/卡比多巴输液.
- 它正在研究与口服利沃多巴/卡比多巴结合用于PD管理.
研究的目的:
- 评估ND0612的3年安全性和有效性.
- 评估PD患者经历运动波动的长期结果.
主要方法:
- 在BeyoND研究的开放式扩展阶段.
- 包括完成12个月ND0612治疗的参与者.
- 收集高达36个月的安全性和有效性数据.
主要成果:
- 保持率很高:在2年后83.3%,在3年后67.5%.
- 36个月后,OFF时间平均减少2.81小时,Good ON时间增加2.79小时.
- 输液部位反应很常见,但很少导致停止治疗.
结论:
- 三年的结果支持ND0612的长期安全性,耐受性和有效性.
- 参与者保留率高表明有利的利益风险比率.
- ND0612为PD运动波动提供了持续的治疗选择.
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