Early primary Parkinson's disease
Conditions
Interventions
experimental group:LY03003
control group:placebo
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
30 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject or his legal representative understands and is willing to participate in this clinical study, voluntarily signs the informed consent and dated. 2. According to the investigator's judgment, the subject or his legal representative is considered to be trustworthy and able to comply with the research protocol, the visit plan or the prescribed study drug treatment. 3. At the time of screening (visit 1), the subject is >= 30 years old, regardless of gender. 4. The subject has a time of primary Parkinson's disease = 25 points. 7. At baseline (visit 2), the Unified Parkinson's Disease Rating Scale (UPDRS) exercise score (Part III) in the "on" state is >= 10. 8. If the subject is receiving anticholinergic drugs (such as benzalkonium, trihexyphenidate, dimethazine, proguanidine, and biperiden), monoamine oxidase B (MAO-B) inhibitors (Treatment with selegiline, rasagiline, and N-methyl-d-aspartate (NMDA) antagonists (eg amantadine) must be stable for at least 28 days prior to baseline (Visit 2) And maintaining the dose during the study. 9. Women of childbearing age (eg, women who have not undergone surgical sterilization or less than one year after menopause) or male subjects agree to take reliable contraceptives (oral contraceptives throughout the study period (screening visits to the end of the study), When using condoms, abstinence, etc., and screening (visit 1) and baseline (visit 2), the pregnancy test results for women of childbearing age were negative.
Exclusion criteria
Exclusion criteria: 1. Have a history of globus incision, thalamic damage, deep brain stimulation or fetal tissue transplantation surgery. 2. Suffering from dementia, active mental illness or hallucinations, major depression (Beck Depression Scale - II >= 29 points at baseline [Visit 2]). 3. Patients receiving dopamine agonist therapy within 28 days prior to baseline (Visit 2). 4. Receive levodopa preparation (including levodopa combination) within 28 days before baseline (visit 2), or levodopa preparation after treatment for more than 6 months. 5. Received any of the following medications within 28 days prior to baseline (Visit 2): amphetamine, metoclopramide, alpha-methyldopa, anti-schizophrenia drugs, monoamine oxidase A (MAO-A) inhibitors , reserpine, methylphenidate, cloth, etc.. 6. Receiving central nervous system active drug therapy (eg sedatives, hypnotics, antidepressants, anxiolytics), but has remained stable for at least 28 days prior to baseline (Visit 2) and may remain stable during the study period By. 7. Due to medication (such as metoclopramide, flunarizine), nervous system hereditary metabolic diseases (such as Wilson's disease), encephalitis, cerebrovascular disease or degenerative diseases (such as progressive nuclear Atypical Parkinson's disease symptoms caused by palsy; 8. Have a history of epilepsy, or have a history of stroke or transient ischemic attack within 1 year prior to screening visits. 9. Those who are intolerant or allergic to the following antiemetics, such as domperidone, trimethoprim, ondansetron, tropisetron, granisetron, and glycopyrrolate. 10. Patients with clinically significant liver dysfunction, defined as 1.5 times the upper limit of total bilirubin > reference range or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of reference range 2 times. 11. Patients with clinically significant renal dysfunction (serum creatinine > 2.0 mg/dL [>177 µmol/L]). 12. Uncontrolled or important cardiovascular disease, including New York Heart Association (NYHA) grade II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first study drug administration, or There is arrhythmia in need of treatment at screening (Visit 1). 13. Screening (Visit 1), QTc interval: male > 470ms, female > 480ms. 14. A history of symptomatic orthostatic hypotension; or a reduction in systolic blood pressure >= 20 mmHg or diastolic blood pressure from the supine position to the upright position at 1 or 3 minutes during screening (visit 1) and baseline (visit 2) Reduce >= 10mmHg; or screen (visit 1) and baseline (visit 2) when the systolic pressure <105mmHg. 15. Subjects with evidence of impulsive control disorder (ICD) when screening (visit 1). 16. There is a history of suicide attempts (including actual attempts, attempts to be interrupted or failed attempts) or suicidal ideation in the past 6 months, defined as the Columbia-Suicide Severity Rating Scale (C- at screening (Visit 1) The answer to question 4 or question 5 in SSRS) is yes. 17. Those with a history of narcolepsy. 18. Screening (Visit 1) For the first 5 years of alcohol, drug abuse, and drug abuse history, alcoholism is defined as drinking more than 14 units of alcohol per week (1 unit = 360 ml beer or 45 ml alcohol with 40% alcohol or 150 ml wine). 19. Patients with malignant tumors within 5 years prior to screening, fully treated cervical carcinoma in situ, cutaneous basal cells or squamous ce
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the total score of the UPDRS scale (II+III) from baseline from baseline to the end of the double-blind dose maintenance period.; | — |
Secondary
| Measure | Time frame |
|---|---|
| At the end of the maintenance period from baseline to double-blind dose, the proportion of patients with a decrease in the total score of the UPDRS scale (II+III) =20%, =25%, =30%;;Changes from Part II of the UPDRS scale relative to baseline from baseline to the end of the double-blind dose maintenance period;;Changes from Part III of the UPDRS scale relative to baseline from baseline to the end of the double-blind dose maintenance period;;At the end of the maintenance period from baseline to the double-blind dose, the CGI scored the severity of the disease (SI) score relative to baseline, the second overall efficacy (GI) score, and the third efficacy index. (EI) score;;Changes from the baseline to the double-blind dose maintenance period, the Principal Parkinson's Disease Questionnaire (PDQ-8) score relative to baseline;;The change in the Parkinson's Disease Sleep Disorder Scale (PDSS) score from baseline from baseline to the end of the double-blind dose maintenance period;;Changes from the Beck Depression Scale-II (BDI-II) score relative to baseline from baseline to the end of the double-blind dose maintenance period;; | — |
Countries
China
Contacts
Public ContactWei Song
West China Hospital of Sichuan University
Outcome results
None listed