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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-07-07
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
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).
WD-1603placebo tablets-matching the active groups.
Placebo of WD-1603Eligibility
primary outcomes
Time frame: 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.
secondary outcomes
Time frame: 14 days-from the baseline to the 14th day
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.
Time frame: Day -21- -2, Day -1, Day 14, and Day 27
Complete the MDS-Unified Parkinson's Disease Rating Scale-Part II (MDS-UPDRS-II) assessment on the morning of each visiting period.
Time frame: 14 days and 27 days-from the baseline to the 14th and 27th day
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.
Time frame: 1 day- on the 28th day
To evaluate Cmax (Maximum Plasma Concentration) of the pharmacokinetics of WD-1603 on the 28th day.
Time frame: 1 day- on the 28th day
To evaluate Cmin (Minimum Plasma Concentration) of the pharmacokinetics of WD-1603 on the 28th day.
Time frame: 1 day- on the 28th day
Publications
No exact PMID-linked public article is currently readable locally.
To evaluate the AUC (Area under the plasma concentration versus time curve) of the pharmacokinetics of WD-1603 on the 28th day.
Time frame: 1 day- on the 28th day
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.
Time frame: 28 days-from baseline to the 28th day.
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.
Time frame: 28 days-from baseline to the 28th day.
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.