NCT04787965已完成不适用
Opicapone Treatment Initiation Open-Label Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- ONGENTYS treatment patterns
研究概览
简要总结
This is an observational study to describe the treatment patterns and clinical outcomes observed with use of ONGENTYS as adjunctive treatment to levodopa/carbidopa in Parkinson's disease patients experiencing "off" episodes with motor fluctuations
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to complete electronic patient-reported outcome instruments
- •Parkinson's disease patients experiencing "off" episodes
- •Patient receiving concomitant levodopa/carbidopa, and as deemed appropriate by the physician, newly initiating ONGENTYS as adjunctive treatment
排除标准
- •Patient is not cognitively able to complete the study requirements
- •Patient is not able to complete the study duration of 6 months
- •History of moderate or severe hepatic impairment
- •Patient has end-stage renal disease
- •Concomitant use of non-selective monoamine oxidase (MAO) inhibitor or catechol-O-methyltransferase (COMT) inhibitors (patients entering study may switch from other COMT inhibitors to ONGENTYS)
- •History of pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasms
- •Currently enrolled in an interventional clinical trial
- •Currently or previously received ONGENTYS
研究组 & 干预措施
ONGENTYS
Opicapone 50 mg capsule once daily for 6 months
干预措施: Opicapone (Drug)
结局指标
主要结局
ONGENTYS treatment patterns
时间窗: 6 months
Reason for initiating treatment and discontinuation
次要结局
- MDS-UPDRS Parts I, II, and IV(6 months)
- NoMoFa(6 months)
- CGI-C(6 months)
- PGI-C(6 months)
- PD Status(6 months)
- PDQ-8(6 months)
研究者
研究点 (1)
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