Motor symptoms including tremor, rigidity, bradykinesia and postural instability, as well as sleep disorders, olfactory dysfunction, autonomic nervous system dysfunction, cognitive and psychiatric disorders
Conditions
Interventions
Experimental Group 1:VG081821AC 50 mg
Experimental Group 2:VG081821AC 25 mg
Experimental Group 3:VG081821AC 75 mg
Sponsors
Capital Medical University Xuanwu Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female individuals aged between 18 and 80 years old (inclusive); 2. Diagnosed with Parkinson's disease according to the "Diagnostic Criteria for Parkinson's Disease in China" (2016 edition), with the first diagnosis = 22 in the third part of the MDS-UPDRS during the screening; 5. Within the past 4 weeks prior to screening, did not take any antiparkinsonian drugs containing levodopa (note: patients who have taken antiparkinsonian drugs containing levodopa before can participate in this trial after a 4-week washout period); 6. Before screening, patients received amantadine and/or anticholinergic drugs, and must have been on a stable treatment regimen for at least 4 weeks before screening, and the dosage should not be changed during the study; 7. For fertile women, the pregnancy test result at the time of screening must be negative, and the participant agrees to use recognized contraceptive measures throughout the study period; 8. Must provide written informed consent, be willing and able to follow the trial protocol (such as being able to understand and complete the questionnaire, following the visit plan, and using the medication).
Exclusion criteria
Exclusion criteria: 1. The presence of any medical condition that may interfere with full participation in the study, including, but not limited to, a current diagnosis of active epilepsy; Had taken dopamine receptor agonists, monoamine oxidase inhibitors, catechol-O-methyltransferase (COMT) inhibitors, adenosine A2A receptor antagonists or drugs with dopamine receptor antagonistic effects within 4 weeks before screening (note: for patients undergoing acute dopamine load test, that is, taking a certain dose of levodopa [such as Madopar] or dopamine receptor agonists [such as Apomorphine] once, after a 3-day washout period, they can be enrolled); 7. Plan to take drugs that inhibit or induce efflux transporters (P-gp, BCRP) during the study; 8. At screening, had uncontrolled hypertension (treated or untreated), defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg (note: after establishing good blood pressure control within a reasonable time, the researcher can optionally allow re-measurement of blood pressure until the baseline visit); 9. Participants have clinically significant liver dysfunction (defined as total bilirubin and/or direct bilirubin, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) above the upper limit of the reference range and evaluated by the researcher to be clinically significant); 10. One of the following conditions exists: positive hepatitis B surface antigen; positive hepatitis C virus antibody; positive hepatitis E virus antibody; positive human immunodeficiency virus (HIV) test; positive syphilis spirochete test; 11. Previous no response to high-dose levodopa (excluding cases of malabsorption) or no response to adequate dopamineergic treatment; 12. Participants have clinically significant renal dysfunction (creatinine clearance rate Ccr 23, or any problem on the Hamilton Anxiety Scale (HAMA) with a score > 21; 14. The researcher determines that the participant has severe mental disorders (anxiety, depression), and the screening criteria include: a score > 23 on the Hamilton Depression Scale-17 (HAMD-17), or a score > 21 on the Hamilton Anxiety Scale (HAMA); 15. The participant has obvious cognitive dysfunction or dementia, including the following situations: illiterate participants (uneducated) with an MMSE score 6 years) with an MMSE score <= 23 at screening; 16. History of surgical treatment for Parkinson's disease; 17. Within 4 weeks before screening, the participant has received traditional rehabilitation methods such as repetitive transcranial magnetic stimulation, transcranial direct current stimulation, biofeedback therapy, acupuncture therapy, and traditional Chinese medicine treatment (note: patients can participate in this trial aft
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in MDS-UPDRS Part III (Motor Examination) scores at Week 12 between the treatment group and placebo group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative change from baseline in MDS-UPDRS Part III (Motor Examination) scores from baseline to Week 12 of treatment;Change from baseline in MDS-UPDRS Part II scores at Week 12 between the treatment group and placebo group;Change from baseline in MDS-UPDRS Part II+lll scores at Week 12 between the treatment group and placebo group;Relative change from baseline over time in MDS-UPDRS Part III (Motor Examination) – Tremor subscores from baseline to Week 12 of treatment;Change from baseline in MDS-UPDRS Part I scores at Week 12 between the treatment group and placebo group;Relative change from baseline over time in MDS?UPDRS Part III (Motor Examination) – Rigidity subscores from baseline through Week 12;Types, counts, number of subjects and incidence rates of adverse events (AEs) and serious adverse events (SAEs) throughout the study period;Relative change from baseline over time in combined MDS?UPDRS Part II + III scores from baseline through Week 12;Change from baseline in MDS?UPDRS Part III (Motor Examination) scores at Week 12 between treatment and placebo groups for participants with age at PD onset =50 years at screening;Relative change from baseline over time in MDS?UPDRS Part III (Motor Examination) – Bradykinesia subscores from baseline through Week 12; | — |
Countries
China
Contacts
Public ContactChen Biao
Capital Medical University Xuanwu Hospital
Outcome results
None listed