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
Overview
- Phase
- Phase 2
- Intervention
- WD-1603 Carbidopa-Levodopa Extended-Release Tablets
- Conditions
- Parkinson Disease
- Sponsor
- Shanghai WD Pharmaceutical Co., Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 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.
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
25/100mg treatment group
25/100mg WD-1603
Intervention: WD-1603 Carbidopa-Levodopa Extended-Release Tablets
25/150mg treatment group
25/150mg WD-1603
Intervention: WD-1603 Carbidopa-Levodopa Extended-Release Tablets
2x25/100mg treatment group
2x25/100mg WD-1603
Intervention: WD-1603 Carbidopa-Levodopa Extended-Release Tablets
placebo group
placebo are tablets-matching with the same active groups.
Intervention: Placebo
Outcomes
Primary Outcomes
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.
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
- 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.)