NCT05036473

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai WD Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-12
• Primary completion: 2022-05-16
• Completion: 2022-09-16
• First posted: 2021-09-05
• Last updated: 2021-11-01

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study