A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease

WD Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: Placebo; Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05036473

WD-1603-2001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

25/100mg treatment group

Experimental group

Description:

25/100mg WD-1603

Treatment:

Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets

25/150mg treatment group

Experimental group

Description:

25/150mg WD-1603

Treatment:

Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets

2x25/100mg treatment group

Experimental group

Description:

2x25/100mg WD-1603

Treatment:

Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets

placebo group

Placebo Comparator group

Description:

placebo are tablets-matching with the same active groups.

Treatment:

Drug: Placebo