Clinical trial NCT05036473: A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: WD-1603
Carbidopa-Levodopa Extended-Release Tablets
Lead sponsor: Shanghai WD Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male/female patients with early Parkinson's disease who are over 30 years old and under 75 years old (including cut-off values).
2. Able to understand and willing to sign an informed consent form (ICF) voluntarily.
3. The diagnosis of Parkinson's disease complies with idiopathic Parkinson's disease (2015 version of MDS Parkinson's disease diagnostic criteria).
4. Modified Hoehn and Yahr Scale≥1, ≤2.5 points.
5. Agree to use medically acceptable contraceptive methods throughout the study and within 1 month after completing the study.

Exclusion Criteria:

1. Have a history of severe allergic reactions or allergies to levodopa or carbidopa.
2. Pregnancy or breastfeeding.
3. Diagnosed as atypical Parkinson's disease or any known secondary Parkinson's syndrome.
4. The investigator believes that the placebo treatment cannot be tolerated.
5. Acute psychosis or hallucinations, using any antipsychotic to treat psychosis or clinically obvious depression.
6. History of epilepsy or epilepsy.
7. The history of narrow-angle glaucoma.
8. Subjects with a history of malignant melanoma.
9. Patients with obvious cognitive impairment.
10. The investigator believes that there are clinically significant medical or surgical diseases and patients who are not suitable for participating in clinical trials.

Primary outcomes:
measure: 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.
timeFrame: 27 days- from the baseline to the 27th day
Secondary outcomes:
measure: 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.
timeFrame: 14 days-from the baseline to the 14th day
measure: 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.
timeFrame: Day -21- -2, Day -1, Day 14, and Day 27
measure: 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.
timeFrame: 14 days and 27 days-from the baseline to the 14th and 27th day
measure: To evaluate Cmax
timeFrame: 1 day- on the 28th day
measure: To evaluate Cmin
timeFrame: 1 day- on the 28th day
measure: To evaluate the AUC
timeFrame: 1 day- on the 28th day
measure: To evaluate levodopa blood concentration fluctuation index.
timeFrame: 1 day- on the 28th day
measure: To evaluate reported adverse events (AEs) of WD-1603 in patients with Parkinson's disease.
timeFrame: 28 days-from baseline to the 28th day.
measure: To evaluate Beck Depression Inventory-II (BDI-II) scale of WD-1603 in patients with Parkinson's disease.
timeFrame: 28 days-from baseline to the 28th day.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Huashan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai WD Pharmaceutical Co., Ltd.
name: Xiaoxiong(Jim) Wei, MD,PhD
role: STUDY_DIRECTOR
References: