A Phase II Randomized, Parallel, Double-blind, Placebo-controlled, Multi-center Clinical Trial of the Efficacy and Safety of WD-1603 Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare the changes from the baseline mean value before the study to the mean value on the 27th day of the study between each dose group and the placebo group.
研究概览
简要总结
It is a phase II randomized, parallel, double-blind, placebo-controlled, multi-center clinical trial of the efficacy and safety of WD-1603 Carbidopa-Levodopa Extended-Release Tablets in patients with Parkinson's disease. The objective of the study is to access the safety and efficacy of WD-1603 carbidopa-levodopa extended-release tablets in patients with Parkinson's disease.
详细描述
Eligible subjects of the study will be randomly assigned into four groups at a ratio of 1:1:1:1: three treatment groups and one placebo group. The subjects will take trial drugs orally three times a day, in the morning before meals, and the second and third medications will be taken after meals, once every 5 hours.
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
- Double (Participant, Investigator)
盲法说明
The active drugs and placebo are labeled from the company and the study staff will give the drug to the subjects who are randomized.
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/female patients with early Parkinson's disease who are over 30 years old and under 75 years old (including cut-off values).
- •Able to understand and willing to sign an informed consent form (ICF) voluntarily.
- •The diagnosis of Parkinson's disease complies with idiopathic Parkinson's disease (2015 version of MDS Parkinson's disease diagnostic criteria).
- •Modified Hoehn and Yahr Scale≥1, ≤2.5 points.
- •Agree to use medically acceptable contraceptive methods throughout the study and within 1 month after completing the study.
排除标准
- •Have a history of severe allergic reactions or allergies to levodopa or carbidopa.
- •Pregnancy or breastfeeding.
- •Diagnosed as atypical Parkinson's disease or any known secondary Parkinson's syndrome.
- •The investigator believes that the placebo treatment cannot be tolerated.
- •Acute psychosis or hallucinations, using any antipsychotic to treat psychosis or clinically obvious depression.
- •History of epilepsy or epilepsy.
- •The history of narrow-angle glaucoma.
- •Subjects with a history of malignant melanoma.
- •Patients with obvious cognitive impairment.
- •The investigator believes that there are clinically significant medical or surgical diseases and patients who are not suitable for participating in clinical trials.
研究组 & 干预措施
25/100mg treatment group
25/100mg WD-1603
干预措施: WD-1603 Carbidopa-Levodopa Extended-Release Tablets (Drug)
25/150mg treatment group
25/150mg WD-1603
干预措施: WD-1603 Carbidopa-Levodopa Extended-Release Tablets (Drug)
2x25/100mg treatment group
2x25/100mg WD-1603
干预措施: WD-1603 Carbidopa-Levodopa Extended-Release Tablets (Drug)
placebo group
placebo are tablets-matching with the same active groups.
干预措施: Placebo (Drug)
结局指标
主要结局
To compare the changes from the baseline mean value before the study to the mean value on the 27th day of the study between each dose group and the placebo group.
时间窗: 27 days- from the baseline to the 27th day
To compare the changes from the baseline mean value before the study to the mean value on the 27th day of the study of the sum of MDS-Unified Parkinson's Disease Rating Scale-Part II (MDS-UPDRS-II) and MDS-Unified Parkinson's Disease Rating Scale-Part III (MDS-UPDRS-III) between each dose group and the placebo group. MDS-UPDRS-II is Motor Experiences of Daily Living, and MDS-UPDRS-III is Motor Examination. Each item is rated on a 5-point Likert-type scale (0-4), with higher scores suggesting more severe impairment.
次要结局
- To compare the change from the baseline mean value before the study to the mean value on the 14th day of the study between each dose group and the placebo group.(14 days-from the baseline to the 14th day)
- To compare the change from the baseline mean value before the study to the mean value on the 14th and 27th days of the study between each dose group and the placebo group.(Day -21- -2, Day -1, Day 14, and Day 27)
- To compare the change from the baseline mean value before the study to the mean value on the 14th and 27th days of the study of MDS-UPDRS-III between each dose group and the placebo group.(14 days and 27 days-from the baseline to the 14th and 27th day)
- To evaluate Cmax(1 day- on the 28th day)
- To evaluate Cmin(1 day- on the 28th day)
- To evaluate the AUC(1 day- on the 28th day)
- To evaluate levodopa blood concentration fluctuation index.(1 day- on the 28th day)
- To evaluate reported adverse events (AEs) of WD-1603 in patients with Parkinson's disease.(28 days-from baseline to the 28th day.)
- To evaluate Beck Depression Inventory-II (BDI-II) scale of WD-1603 in patients with Parkinson's disease.(28 days-from baseline to the 28th day.)