Efficacy and Safety of Opicapone in Parkinson's Disease Add -on to Levodopa Carbidopa Intestinal Gel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Evaluation of motor fluctuations changes
研究概览
简要总结
Levodopa-Carbidopa intestinal gel (LCIG) is an effective therapy for complicated Parkinson's disease (PD). Few studies have explored the efficacy and safety of the potential combination of LCIG with catechol-O-methyltransferase (COMT) inhibitors, particularly Opicapone (OPC).
详细描述
22 PD patients were randomized into LCIG monotherapy (n-OPC 11 patients) and LCIG+OPC (add-OPC 11 patients), further divided according to OPC adding time (E-OPC within one month and L-OPC after one month from LCIG implant).
Data on PD clinical aspects, Montreal Cognitive Assessment (MoCA), Unified Parkinson's Disease Rating Scale (UPDRS), Unified Dyskinesia Rating Scale (UDysRS), electroneurography (ENG), and pharmacological therapy (Levodopa Equivalent Dose-LEDD) were collected before LCIG implanted (T0) and in the following 12 (T1) months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LCIG implantation not longer than 30 months before the study enrollment,
- •Presence of nocturnal akinesia (assessed by medical history and through item 2.9 of MDS-UPDRS part II (> 2), or/and
- •Persistence of morning or afternoon akinesia (assessed by item 4.3 in MDS UPDRS -IV( >2 ).
排除标准
- •Hoehn & Yahr (H&Y) >4,
- •Cognitive decline (MOCA< 17),
- •more than 30 months after LCIG positioning,
- •not compliant with treatment and follow-up visits.
研究组 & 干预措施
nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy
Levodopa carbidopa intestinal gel infusion. Diurnal infusion from 7.a.m to 11 p.m.
干预措施: Duodopa (Drug)
add-OPC: Duodopa plus OPC therapy
Levodopa carbidopa intestinal gel infusion (Diurnal infusion from 7 a.m to 11 p.m) plus Opicapone 50 mg 1 tablet at nighttime (11 p.m)
干预措施: Opicapone 50 mg (Drug)
add-OPC: Duodopa plus OPC therapy
Levodopa carbidopa intestinal gel infusion (Diurnal infusion from 7 a.m to 11 p.m) plus Opicapone 50 mg 1 tablet at nighttime (11 p.m)
干预措施: Duodopa (Drug)
结局指标
主要结局
Evaluation of motor fluctuations changes
时间窗: 12 months
Changes in MDS-UPDRS part IV from the initial assessment to 12 months follow-up.
Evaluation of dyskinesia changes
时间窗: 12 months
Changes in UDysRS from the initial assessment to 12 months follow-up.
次要结局
- Changes in non-motor aspects of patients' daily living experiences(12 months)
- Neurophysiological outcome(12 months)
- Changes in motor aspects of patients' daily living experiences(12 months)
- Changes in non-motor symptoms in Parkinson's disease-cognition(12 months)