| Eligibility |
Inclusion Criteria:
1. Informed consent must be given to the study and written informed consent must be
voluntarily signed, good communication with the investigator and compliance with all
requirements of the clinical trial (planned visits, laboratory tests and other test
procedures);
2. During screening, subjects are 18-80 years old (including boundary value), regardless
of gender;
3. Male subjects shall weigh no less than 50kg and female subjects shall weigh no less
than 45kg. Body mass index within the range of 19~30kg/m2 (including critical value);
4. Meet the diagnostic criteria of MDS for primary Parkinson's disease with sick time
more than 3 years. The diagnosis is based on the main symptoms-motor retardation, plus
at least one of the following symptoms: quiescence tremor, myotonia, and no other
known or suspected causes of Parkinson's disease;
5. In the "on" state, subjects' HOehn-YahR rating is from level 2 to level 3;
6. A concise Mental State Scale (MMSE) score =25;
7. A steady dose of Levodopa (either monotherapy or in combination with
benserazide/carbidopa/carbidopa) shall be administered at least 2 times a day for a
minimum of 28 days prior to baseline;
8. if you are accept anticholinergic drugs (such as benzalkonium tropic, benzene hai suo,
diethyl promethazine, its organism and than pp board), monoamine oxidase B (MAO B)
inhibitors (e.g., company to gillan, LeiSha gillan) and/or N - methyl - d - aspartate
(NMDA) antagonist (such as amantadine) treatment, must be accepted before baseline at
least 28 days, stable doses and during the study period to maintain the therapeutic
dose;
9. Women of childbearing age (those who do not meet any of the following conditions:
menstrual stop = 12 months; Or had undergone hysterectomy or bilateral oophorectomy;
(or with medically confirmed ovarian failure) or male subjects agree to use reliable
contraceptives (oral contraceptives, condom use, abstinence, etc.) throughout the
study period (screening visits until the end of the study), and pregnancy tests for
women of childbearing age are negative at screening and baseline.
Exclusion Criteria:
1. Patients with atypical Parkinson's disease caused by the use of drugs (such as
methoxylopramine, flunarizine), hereditary metabolic diseases of the nervous system
(such as Wilson's disease), encephalitis, cerebrovascular diseases or degenerative
diseases (such as progressive supravuclear palsy);
2. The author had a history of epilepsy, or had a history of stroke or transient ischemic
stroke within 1 year before the visit;
3. Dementia, active mental illness or hallucinations, major depression;
4. Those with a history of suicide attempts (including actual attempts, attempts
interrupted or failed) or suicidal ideation in the past 6 months, defined as those who
answered "yes" to question 4 or 5 on the Columbia-Suicide Severity Rating Scale
(C-SSRS) at the time of screening;
5. Patients with a history of narcolepsy;
6. There is impulse control disorder (ICD) evidence;
7. Uncontrolled or severe cardiovascular disease, including New York Heart Association
(NYHA) class II or higher congestive heart failure, unstable angina, myocardial
infarction, or the presence of arrhythmia requiring treatment during screening;
8. Patients with malignant tumors within 5 years before screening, except for cervical
carcinoma in situ, basal cell or squamous cell carcinoma of the skin, local prostate
cancer after radical surgery, and intraductal carcinoma in situ after radical surgery;
9. History of pallidotomy, thalamic lesion, deep brain stimulation or fetal tissue
transplantation;
10. received cabergoline or bromocriptine within 15 days before baseline, or received
other dopamine agonists within 7 days before baseline;
11. Patients received any of the following drugs within 28 days before baseline:
a-methyldopa, metoclopramide, flunarizine, reserpine, antipsychotics, monoamine
oxidase A (MAO-A) inhibitors, methylphenidate, amphetamine, cloth, etc.;
12. Currently receiving treatment for central nervous system diseases (e.g., sedatives,
hypnotics, antidepressants, anxiolytics), unless the dose is stable for at least 28
days before baseline, and the treatment dose is maintained during the study period;
13. Known history of intolerance/allergy to the following antiemetics: domperidone,
trimethoxybenzamide, ondansetron, tropisetron, granisetron, and glycopyrrolate;
14. Screening or baseline, ECG examination QTc > 450 milliseconds (male) or > 460
milliseconds (female) or other abnormalities judged by the investigator have clinical
significance;
15. History of orthostatic hypotension; or systolic blood pressure (SBP) decreased by = 20
mmHg or diastolic blood pressure (DBP) decreased by = 10 mmHg when changing from the
decubitus position to the upright position for 1 or 3 minutes at screening or
baseline; or systolic pressure < 105 mmHg at screening or baseline;
16. Clinically significant abnormal liver function, defined as total bilirubin > 1.5 times
the upper limit of the reference range or alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) > 2 times the upper limit of the reference range;
17. Clinically significant renal dysfunction (serum creatinine > 2.0 mg/dL or > 177
umol/L]);
18. Any test result of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV)
antibody, human immunodeficiency virus (HIV) antibody is positive;
19. Smokers, alcoholics:
A) Smoking is defined as: an average daily smoking of = 5 cigarettes within 3 months
before screening; B) Alcohol abuse is defined as: drinking more than 14 units of
alcohol per week (1 unit = 350 mL of beer, or 45 mL of liquor, or 150 mL of wine)
within 3 months before screening.
20. Pregnant or lactating women;
21. Allergic constitution (allergic to two or more drugs or food) or known to be allergic
to rotigotine or rotigotine microsphere preparation ingredients;
22. Previous use of rotigotine-containing preparations can not tolerate or poor efficacy;
23. Participated in other drug clinical trials within 3 months before screening;
24. Other clinically significant medical conditions, mental conditions or laboratory
abnormalities that may interfere with the ability of the subject to participate in
this study as judged by the investigator;
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