Early and middle stage Parkinson's disease
Conditions
Interventions
experimental group :LS001
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent; 2. The age at the time of signing the informed consent form is >= 18 years old, and the proportion of elderly people >= 65 years old shall not be less than 75%, regardless of gender; 3. Diagnosed with Parkinson's disease according to the International Movement Disorder Society (MDS) Parkinson's disease diagnostic criteria, Hoehn-Yahr grade <= 3; 4. Subjects who have not received anti-PD drug treatment within 4 weeks before the first administration; if the subject is receiving anti-PD drug treatment, if the subject wants to participate in the study, he needs to stop taking the drug for 4 weeks before the first administration ; 5. Female subjects need to undergo FSH examination during screening; 6. Male subjects, if they have sex with women of childbearing age, must agree to use effective contraceptive methods during the study period and within 6 months after the last medication; 7. The nucleic acid test result of the new coronavirus nucleic acid (throat swab) is negative.
Exclusion criteria
Exclusion criteria: 1. Received the following anti-PD drugs within 28 days before the first dose; including but not limited to the following: dopamine receptor agonists, anticholinergic drugs, monoamine oxidase B (MAO-B) inhibitors, N-methyl-D-Aspartic acid (NMDA) receptor antagonists, levodopa preparations (including levodopa compound preparations) and catechol-O-methyltransferase inhibitors; 2. Patients with Parkinson's symptoms who have received surgical treatment within 28 days before the first administration; 3. Patients with atypical Parkinson's symptoms caused by drug use or disease; 4. Those who have received neurosurgery or electrical stimulation therapy (such as pallidotomy, thalamotomy, deep brain electrical stimulation, etc.); 5. Patients with glaucoma, enlarged prostate and symptoms, epilepsy, syncope, stroke, dementia, active mental illness, hallucinations, or transient cerebral ischemia in the past year; 6. Patients with malignant tumors within 5 years prior to screening (except adequately treated cervical carcinoma in situ, skin basal cell or squamous cell carcinoma, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery); 7. Suffering from any of the following heart diseases: (1) Suffering from uncontrolled or severe cardiovascular diseases, including congestive heart failure above New York Heart Association (NYHA) grade II, unstable angina, myocardial infarction within 6 months before the first dose, or there are arrhythmias that need treatment during screening; (2) Suffering from hypertension (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg), which cannot be reduced to the normal range after combined treatment with two or more antihypertensive drugs (systolic blood pressure: 90-140 mmHg, diastolic blood pressure: 60-90 mmHg); (3) Suffering from symptomatic orthostatic hypotension, blood pressure in the supine position must be measured first during the screening period, measured after lying down in the supine position for 5 minutes, and then the subject changed from the supine position to an upright position for about 3 minutes to measure the systolic blood pressure (SBP) reduction >= 30 mmHg or diastolic blood pressure (DBP) reduction >= 15 mmHg; (4) With clinically significant ECG abnormalities, such as QRS time > 120 ms; long QT syndrome; QTcF interval > 460 ms (male); QTcF interval > 480 ms (female); 8. There is a history of significant food and drug allergy or hypersensitivity reactions judged by the investigator to be clinically significant, especially to ingredients similar to the drug in this study; 9. Participated in other clinical trials 12 weeks before signing the informed consent or within 5 half-lives of the drug (whichever is longer); 10. Those who have a history of alcohol dependence, drug abuse, and drug abuse within 1 year before the screening period; 11. Blood loss or blood donation exceeding 400 mL within 3 months before screening; 12. Patients with diseases that seriously affect drug absorption, metabolism, and excretion; 13. Patients who have previously participated in LS001 drug trials; 14. The investigator judges that the subject has other conditions that are not suitable for participating in this clinic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs;physical examination;clinical laboratory tests;12-lead electrocardiogram (ECG) examination;adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| MDS Unified-Parkinson Disease Rating Scale, MDS-UPDRS;clinical global impression scale;pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactBaorong Zhang
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed