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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25/100mg treatment group | Experimental | 25/100mg WD-1603 |
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| 25/150mg treatment group | Experimental | 25/150mg WD-1603 |
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| 2x25/100mg treatment group | Experimental | 2x25/100mg WD-1603 |
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| placebo group | Placebo Comparator | placebo are tablets-matching with the same active groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WD-1603 Carbidopa-Levodopa Extended-Release Tablets | Drug | Taking WD-1603 tablets or placebo 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 (±30 minutes). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 27 days- from the baseline to the 27th day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | To compare the changes from the baseline mean value before the study to the mean value on the 14th 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoxiong(Jim) Wei, MD,PhD | Shanghai WD Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Huashan Hospital | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Active groups are the groups of Parkinson's disease patients who will receive WD-1603 tablets with 3 different dosages.
Placebo group is the group of Parkinson's disease patients who will receive the placebo-matching tablets.
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The active drugs and placebo are labeled from the company and the study staff will give the drug to the subjects who are randomized.
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| Placebo | Drug | placebo tablets-matching the active groups. |
|
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| 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. | Complete the MDS-Unified Parkinson's Disease Rating Scale-Part II (MDS-UPDRS-II) assessment on the morning of each visiting period. | 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. | During the screening period, an outpatient evaluation is performed before administration. In the other visit periods, 6 assessments of the MDS-Unified Parkinson's Disease Rating Scale-Part III (MDS-UPDRS-III) are carried out at the time point of the clinical trial administration. | 14 days and 27 days-from the baseline to the 14th and 27th day |
| To evaluate Cmax | To evaluate Cmax (Maximum Plasma Concentration) of the pharmacokinetics of WD-1603 on the 28th day. | 1 day- on the 28th day |
| To evaluate Cmin | To evaluate Cmin (Minimum Plasma Concentration) of the pharmacokinetics of WD-1603 on the 28th day. | 1 day- on the 28th day |
| To evaluate the AUC | To evaluate the AUC (Area under the plasma concentration versus time curve) of the pharmacokinetics of WD-1603 on the 28th day. | 1 day- on the 28th day |
| To evaluate levodopa blood concentration fluctuation index. | To evaluate levodopa blood concentration fluctuation index of WD-1603 on the 28th day. Plasma levodopa is summarized according to the blood sampling time point of the protocol; describe and compare the mean of the blood concentration of levodopa and carbidopa in each dose group, and calculate the fluctuation index ([Cmax-Cmin]/Cavg, Cavg= AUC0-t/t), where Cmax is Maximum Plasma Concentration, Cmin is Minimum Plasma Concentration, Cave is Average Plasma Concentration, AUC0-t is Area under the Plasma Concentration versus Time Curve Calculated from 0 to the Last Measurable Observation. | 1 day- on the 28th day |
| To evaluate reported adverse events (AEs) of WD-1603 in patients with Parkinson's disease. | AEs refer to all adverse medical events in clinical research subjects, which can be manifested as symptoms and signs, diseases, or abnormal laboratory tests, but they may not have a causal relationship with the study drug. The following must be recorded as AE when at least one of the following criteria is met: 1. Accompanying symptoms and signs; 2. The results of the examination require treatment measures (such as surgical intervention); 3. The result of the inspection leads to changes in the dosing schedule of the study drug (such as dose change, dosing delay, discontinuation) of the study. The following can be referred to do AE severity classification. 1 (Mild): Asymptomatic or mild; only clinically seen; 2(Moderate): Requires minor, or non-invasive treatment; 3 (Severe): Severe or medically significant but not immediately life-threatening; 4 (Life-threatening): Urgent treatment is needed; 5 (Death): Death related to adverse events. | 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. | BDI-II scores are collected for safety assessment. BDI-II is a 21-item self-administered survey which is scored on a scale of 0-3 in a list of four statements arranged in increasing severity about a particular symptom of depression. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. | 28 days-from baseline to the 28th day. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |