VG081821AC Tablets for Early to Mid-stage Parkinson's Disease
ConditionParkinson Disease (PD)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhejiang Vimgreen Pharmaceuticals, Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged 18 ≤ Age ≤ 80 at the time of signing the informed consent.
Diagnosed with Parkinson's disease per the Chinese Diagnostic Criteria for Parkinson's Disease (2016 Edition), and time from initial diagnosis ≤ 7 years.
Modified Hoehn-Yahr scale rated as 1~3 (inclusive) at screening.
MDS-UPDRS Part III score ≥ 22 at screening.
Disqualifiers
Presence of any medical condition that may interfere with full participation in the study, including but not limited to the following: current diagnosis of active epilepsy; history of hemolytic anemia, pulmonary embolism, respiratory depression, dementia, active psychiatric disease, severe depression, or malignant tumor.
History of congestive heart failure (New York Heart Association functional class 3 or 4) or known left ventricular ejection fraction <30%.
History of angina pectoris, myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, peripheral arterial bypass surgery, transient ischemic attack (TIA), or stroke within 3 months prior to screening.
History of arrhythmia or presence of uncontrolled arrhythmia, including but not limited to: atrial fibrillation, Wolff-Parkinson-White syndrome, congenital long QT syndrome, and ECG indicating QTc interval prolongation (defined as male (QTc) > 450 ms, female (QTc) > 470 ms); [Fridericia formula: QTc=QT/(RR^0.33), where RR represents the standard heart rate value, calculated by dividing 60 by the heart rate].
Trial design
Design model
Parallel
Treatments tested in this trial
VG081821AC
DrugVG081821AC 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.
Placebo
Other interventionAn 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.
Treatment groups
152 Participants
are divided into 4 treatment groupsGroup A: VG081821AC 25 mg BIDExperimental treatment 1 intervention
Group B: VG081821AC 50 mg BIDExperimental treatment 1 intervention
Group C: VG081821AC 75 mg BIDExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the efficacy of oral VG081821AC tablets in Chinese patients with early to mid-stage Parkinson's disease
The endpoint is the change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) score at week 12 for the experimental and placebo groups.
Time frame
From enrollment to the end of treatment at 12 weeksSecondary outcomes
1
To evaluate the types, occurrences, number of cases, and incidence rates of Adverse Events (AEs) and Serious Adverse Events (SAEs) during the study
Time frame
From enrollment to the end of treatment at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov