Early and middle stage Parkinson's disease
Conditions
Interventions
experimental group:LS001
Control group:placebo
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in this study and sign the informed consent; 2.Aged 18 years and over at the time of signing the informed consent, no gender limitation; 3.Diagnosed with Parkinson's disease according to the International Movement Disorder Society (MDS) Parkinson's disease diagnostic criteria, HoehnYahr grade = 10; 5.Montreal Cognitive Assessment Scale (MoCA) >= 22 (Bachelor degree or below >= 21); 6.Hamilton Depression Scale (HAMD-24) <= 35; 7. Subjects who did not receive anti-PD drug treatment within 4 weeks before the first administration; 8. Female subjects: The serum HCG test of female subjects of childbearing age must be negative, and they must agree to use at least one effective and reliable contraceptive method during the trial and 6 months after the last administration; female subjects of non-childbearing age (FSH examination is required during screening) can be exempted from this standard; 9. Male subjects: male subjects agreed to use reliable contraceptive measures during the study period and within 6 months after the last administration.
Exclusion criteria
Exclusion criteria: 1. Received the following anti-PD drugs within 28 days before baseline; including but not limited to the following (dopamine receptor agonists, anticholinergic drugs, monoamine oxidase B (MAO-B) inhibitors, N-methyl-D-aspartate (NMDA) receptor antagonists, levodopa preparations (including levodopa compound preparations and catechol-O-methyltransferase inhibitors)); 2.Levodopa preparation (including levodopa compound preparation) was taken for more than 6 months before screening; 3. Patients with Parkinson's symptoms who have received surgical treatment within 28 days before baseline; 4. Those with atypical Parkinson's symptoms caused by the use of drugs or diseases; 5. Those who have received neurosurgery or electrical stimulation (such as pallidotomy, thalamotomy, deep brain stimulation, etc.); 6. Previous or existing glaucoma, prostatic hypertrophy, epilepsy, syncope, stroke, dementia, active mental disease, hallucination, or transient cerebral ischemia in recent one year; 7. Patients with malignant tumors within 5 years before screening (except fully treated cervical carcinoma in situ, skin basal cell or squamous cell carcinoma, local prostate cancer after radical operation, breast ductal carcinoma in situ after radical operation, etc.); 8. There was suicide attempt (including active attempt, interrupted attempt or failed attempt) or suicidal ideation within 6 months before screening, and the answer to question 4 or question 5 of Columbia-Suicide Severity Rating Scale (C-SSRS) is yes; 9. Liver function: total bilirubin > 1.5 times the upper limit of normal or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > twice the upper limit of normal value; 10.Renal function: creatinine clearance (Ccr) = 160mmhg and / or diastolic blood pressure >= 100mmhg), and cannot be reduced to the normal range after combined treatment with two or more antihypertensive drugs; (3) Suffer from symptomatic orthostatic hypotension, or reduce systolic blood pressure (SBP) by >= 30mmhg or diastolic blood pressure (DBP) by >= 15mmhg within 3 minutes from supine position to upright position; (4) Having a history of clinically significant ECG abnormalities, QRS time > 120ms, QT prolongation: QTc interval > 450ms (male), QTc interval > 470ms (female); 12. Presence of a history of major food or drug allergy or hypersensitivity judged by the investigator to be clinically significant, especially allergic to ingredients similar to the drug under study; 13. Engaging in high-risk occupations, such as mechanical operations and working at heights, from the time of the first administration to the end of treatment; 14. Those who have participated in other clinical trials within 12 weeks after signing the informed consent or within 5 half-lives of the drug (whichever is longer); 15. Those who have a history of alcoholism, drug abuse, or drug abuse within 1 year before the screening period; 16. Pregnant and lactating patients; 17. Patients who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs;physical examination;Clinical laboratory tests;12-lead electrocardiogram (ECG) examination;adverse events;between group differences in MDS-UPDRS(III) scores at baseline and the ending point; | — |
Secondary
| Measure | Time frame |
|---|---|
| between group differences in MDS-UPDRS scores at baseline and the ending point;between group differences in CGI-SI scores at baseline and the ending point;between group differences in CGI-GI scores at baseline and the ending point;between group differences in PDQ-39 scores at baseline and the ending point; | — |
Countries
China
Contacts
Public ContactChen Biao
Xuanwu Hospital Capital Medical University
Outcome results
None listed