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RECRUITING
NCT07725562
PHASE2/PHASE3

Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of VG081821AC Tablets in Patients With Early to Mid-stage Parkinson's Disease

Sponsor: Zhejiang Vimgreen Pharmaceuticals, Ltd.

View on ClinicalTrials.gov

Summary

This study is testing a new oral medication called VG081821AC to see if it can help improve movement symptoms in people with early to mid-stage Parkinson's disease. VG081821AC works by blocking a protein in the brain called the adenosine A2A receptor, which may help improve motor function without using levodopa. The main goal is to measure changes in movement symptoms using a standard rating scale called the MDS-UPDRS Part III (Motor Examination). This scale evaluates how well participants can move, walk, and perform daily activities. The study will compare the scores before and after 12 weeks of treatment to see if VG081821AC improves movement symptoms better than the placebo. Currently, levodopa is the most common treatment for Parkinson's disease, but it can cause side effects over time. If VG081821AC works well, it could offer a new treatment option for people in the early to mid-stages of Parkinson's disease who want to delay or avoid starting levodopa. A total of 152 adults (aged 18-80 years) will be enrolled in this trial in China. Participants will be randomly assigned (like flipping a coin) to one of four groups: * VG081821AC 25 mg (taken twice daily) * VG081821AC 50 mg (taken twice daily) * VG081821AC 75 mg (taken twice daily) * Placebo (a pill with no active drug, taken twice daily) Participants will visit the study center 8 times to have their movement symptoms, safety, and overall health checked.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of Oral VG081821AC Tablets Monotherapy (Without Concomitant Levodopa) in Patients With Early to Mid-Stage Parkinson's Disease

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2026-07-17

Completion Date

2027-10-31

Last Updated

2026-07-24

Healthy Volunteers

No

Interventions

DRUG

VG081821AC

VG081821AC Tablets: Oral, small-molecule adenosine A2A receptor antagonist (25 mg/tablet) administered BID within 30 min post-meal for 12 weeks. The study evaluates three active dose levels (25 mg, 50 mg, and 75 mg BID), each administered as a fixed combination of three tablets.

OTHER

Placebo

An inert placebo tablet identical in appearance, taste, and packaging to the VG081821AC tablet. It contains no active pharmaceutical ingredient and is formulated with the same excipients as VG081821AC. The placebo is administered as a fixed combination of three tablets via the same route and schedule as the active treatment.

Locations (1)

Xuanwu Hospital of Capital Medical University

Beijing, China