Parkinson's disease
Conditions
Interventions
A1:200mg QD, 28 Days
A2:400mg QD, 28 Days
Sponsors
Zhejiang Xiaoshan Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in clinical trials, sign informed consent forms, understand and follow the protocol, fully understand the content, process and possible adverse reactions of the trials, and indicate the date of signing; 2. Are between the ages of 30 and 80 years, inclusive; 3. Diagnosis of Parkinson's disease according to Diagnostic Criteria of Parkinson's Disease in China (2016 edition); 4. The modified Hoehn-Yahr (H-Y) stage 1 to 4 5. Subjects had not been treated with anti-PD drugs, or had not been treated with anti-PD drugs within 4 weeks prior to the first dose, or had been on stable medication for PD treatment for at least 4 weeks and agreed to keep the original medication regimen during the trial; 6. Subject and his/her partner has no plans to have children, no plans to donate sperm or eggs, and voluntarily use effective contraceptive methods (such as abstinence, condoms, etc.) during the screening period until 6 months after the end of the trial; Male subjects should agree to refrain from donating sperm from the start of dosing until 6 months after stopping study treatment, and female subjects should agree to refrain from donating eggs from the start of dosing until 6 months after stopping study treatment.
Exclusion criteria
Exclusion criteria: 1. Any medical condition that may interfere with full participation in the study, including but not limited to the following: history of epilepsy or complications, hemolytic anemia, pulmonary embolism, respiratory depression, active mental illness, severe Parkinson's disease, or malignant tumor; 2. Any of the following heart conditions (a) uncontrolled or severe cardiovascular and cerebrovascular disease, including New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, acute myocardial infarction, or arrhythmia requiring treatment at the time of screening, in the six months prior to first administration of the drug; b. high blood pressure (systolic blood pressure =160mmHg and/or diastolic blood pressure =100mmHg) that cannot be reduced to the normal range with the combination of 2 or more antihypertensive drugs; c. history of clinically significant ECG abnormalities, QRS time > 120ms, long QT syndrome: QTc interval > 450ms (male), QTc interval > 470ms (female); 3. Subject with clinically significant liver dysfunction (ALT and/or AST above 2 times the upper limit of the reference range) 4. Subject with clinically significant renal insufficiency (creatinine clearance Ccr < 30mL/min); 5. Any medical condition that may confuse the exercise assessment (MDS-UPDRS) over time (e.g. severe arthritis, severe dyspraxia, traumatic injury with permanent physical disability); 6. Subject with history of suicide attempts (including actual attempts, interrupted attempts, or failed attempts) and the investigator evaluates s that the subject is at risk of suicide; 7. Subjects with obvious cognitive dysfunction and dementia 8. Subjects with history of surgical treatment for PD (such as deep brain stimulation, pallidotomy, etc.) or plan to undergo surgical treatment during the study period; 9. Evidence of alcoholism (drinking an average of =14 units of alcohol per week, 1 unit ˜ 360mL of beer, or 45mL of white wine or 150mL of wine) or drug abuse in the past 6 months, which the researcher evaluates will interfere with the understanding of the study or complete the study; 10. History of excessive consumption of tea, coffee and caffeinated beverages in the past 4 weeks (excessive consumption of tea is defined as 4 cups or more a day, 1 cup =250mL, 2 cups, 3 cups and other multi-brewed teas without tea added after one brew are still counted as 1 cup; The consumption of coffee and caffeinated beverages was defined as 2 or more cups per day, 1 cup =250 ml. For subjects who did not drink coffee and caffeinated beverages daily, the consumption of coffee and caffeinated beverages per day per week was allowed to be 2 cups, but not more than 2 cups. And do not exceed the defined drinking during the study); 11. Participated in a clinical study involving the administration of an investigational drug (new chemical entity), device, or procedure within 90 days or 5 half-lives prior to screening, whichever is the older. Subjects can be rescreened after appropriate intervals rather than excluded; 12. Have participated in PD gene therapy trials in the past or at present; 13. Those who have participated in clinical trials of other drugs within 3 months prior to screening; 14. Patients with history of severe drug allergy, or allergic to the study drug excipients; 15. HCV antibody detection, HIV antigen/antibody detection, treponema pallidum antibody detection results are positive; 16. Pregnancy test positive, pregnant, breast-feeding wo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of MDS-UPDRS Part III (Exercise Examination) Score from Baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Changes of MDS-UPDRS Part III (Exercise Examination) score compared with baseline;;2. Changes of MDS-UPDRS Part III (Exercise Examination) score compared with baseline;;3. Changes of the scores of MDS-UPDRS parts ?, ? and ? compared with the baseline(1, 2, 3 and 4 weeks of treatment and 1 week of drug withdrawal);;4. The changes of the total score of MDS-UPDRS compared with the baseline (1, 2, 3 and 4 weeks of treatment and 1 week of drug withdrawal);;5. Changes of Hoehn-Yahr staging compared with baseline (4 weeks of treatment and 1 week after drug withdrawal);;6. Changes of the clinical overall impression scale-severity of illness (CGI-S) and total evaluation of curative effect (CGI-I) compared with the baseline (2, 4 weeks of treatment and 1 week of drug withdrawal);;7. Changes of Parkinson's Patients' Quality of Life Questionnaire (PDQ-39) score compared with the baseline (4 weeks of treatment and 1 week of drug withdrawal); | — |
Countries
China
Contacts
Public ContactJian Chen/Kai Fang
Zhejiang Xiaoshan Hospital
Outcome results
None listed