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COMPLETED
NCT05036473
PHASE2

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

Sponsor: Shanghai WD Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

30 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2021-11-25

Completion Date

2022-12-28

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

DRUG

WD-1603 Carbidopa-Levodopa Extended-Release Tablets

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).

DRUG

Placebo

placebo tablets-matching the active groups.

Locations (1)

Shanghai Huashan Hospital

Shanghai, Shanghai Municipality, China