Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) III Score
研究概览
简要总结
This is a, open-label, single-arm 8-week investigation of levodopa/carbidopa/entacapone in the treatment of early Parkinson's disease.
详细描述
This study will enroll subjects who have a diagnosis of PD with Hoehn-Yahr stage 1.5-3.0 and assess the impact of low dosage of levodopa/carbidopa/entacapone treatment on the motor function and quality of life among PD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female and greater from 30 to
- •Diagnosis of idiopathic PD according to the MDS PD Diagnostic Criteria (2015).
- •Hoehn-Yahr stage of 1.5-3.0 ("open" stage).
- •Not on anti-PD medication or stable on anti-PD medication for at least 30 days.
排除标准
- •Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism.
- •History of surgery within 6 months.
- •Alcoholism, drug abuse, or severe cognitive impairment (including severe Alzheimer's disease)
- •Psychiatric illness, epilepsy, pregnancy and breastfeeding, and clinically significant concomitant illnesses
- •Participation in another clinical trial within 2 months.
- •With dyskinesia.
- •Any other condition that, in the opinion of the investigator, makes them ineligible for enrolment.
研究组 & 干预措施
levodopa/carbidopa/entacapone
levodopa/carbidopa/entacapone is a combination drug consisting of levodopa, carbidopa, and entacapone. Each tablet contains a 1:4 ratio of carbidopa to levodopa and 200 mg of entacapone. The optimum daily dosage of levodopa/carbidopa/entacapone must be determined by careful titration in each patient.
干预措施: levodopa/carbidopa/entacapone (Drug)
结局指标
主要结局
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) III Score
时间窗: Baseline, Week 8
The UPDRS is a standardized assessment scale used to measure the patient's disease state. UPDRS Part III measures the motor function of the patient. A higher score indicates greater disability.
次要结局
- Change From Baseline in UPDRS II Score(Baseline, Week 8)
- Incidence of dyskinesia and wearing off(Baseline, Week 8)
- Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)(Baseline, Week 8)