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

NCT07725562 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-07-24

No results posted yet for this study

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.

Conditions

  • Parkinson Disease (PD)

Interventions

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.

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.

Sponsors & Collaborators

  • Zhejiang Vimgreen Pharmaceuticals, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-17
Primary Completion
2027-10-01
Completion
2027-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725562 on ClinicalTrials.gov