| Eligibility |
Inclusion Criteria:
1. Informed consent must be given to the trial 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
procedures);
2. Age =30 years old, regardless of gender;
3. The subject has had primary Parkinson's disease for less than 5 years, and the
diagnosis is based on the main symptom -- motor delay plus at least 1 symptom:
quiescence tremor, myotonia, and no other known or suspected cause of Parkinson's
disease;
4. Hoehn-yahr grading =3 (excluding 0);
5. Brief mental state examination (MMSE) =25 points;
6. Unified Parkinson disease rating scale (UPDRS) motor score (part ?) 10 or higher;
7. If the subjects are receiving anticholinergic drugs (such as benzalkonium tropic,
benzene hai suo, diethyl promethazine, its organism and than pp board), MAO - B
inhibitors (e.g., company to gillan, LeiSha gillan), NMDA antagonists, such as
amantadine treatment, must dose before baseline stability at least 28 days, and
maintain the dose treatment during the study period
8. Women of childbearing age (defined as women who have not undergone surgical
sterilization or less than 1 year after menopause) or male subjects agree to use
reliable contraceptives (oral contraceptives, condom use, abstinence, etc.) throughout
the study period (until the end of the study), and pregnancy outcomes were negative
for women of childbearing age at screening and baseline.
Exclusion Criteria:
1. History of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue
transplantation
2. Dementia, active mental illness or hallucination, major depression
3. Those who received dopamine receptor agonists within 28 days before baseline
4. Patients receiving levodopa preparation (including levodopa compound preparation)
within 28 days before baseline, or levodopa preparation after diagnosis for more than
6 months
5. Patients receiving any of the following drugs within 28 days before baseline:
amphetamine, metoclopramide, a-methyldopa, antipsychotics, MAO-Ainhibitors,
flunarizine, reserpine, methylphenidate, budesonide, etc
6. Active central nervous system drugs (such as sedatives, hypnotics, antidepressants,
and antianxiety drugs) are under treatment, except those who have maintained a stable
dose for at least 28 days before the baseline (visit 2) and may remain stable during
the study period
7. Atypical Parkinson's disease symptoms caused by taking drugs (such as metoclopramide,
flunarizine), hereditary metabolic diseases of nervous system (such as Wilson's
disease), encephalitis, cerebrovascular diseases or degenerative diseases (such as
progressive supranuclear paralysis)
8. Have a history of epilepsy, or have a history of stroke or transient cerebral ischemia
within 1 year before the visit
9. Those who are intolerant or allergic to the following antiemetic drugs, such as
domperidone, trimethoxybenzamide, ondansetron, tropisetron, granisetron and
glinbromide
10. Patients with clinically significant abnormal liver function were defined as total
bilirubin > 1.5 times of the upper limit of the reference value range or ALT or ast >
2 times of the upper limit of the reference value range
11. Patients with clinically significant renal dysfunction (serum creatinine > 2.0 mg / dl
[> 177 µ mol / l])
12. Patients with uncontrollable or important cardiovascular diseases, including
congestive heart failure of NYHA grade II or above, unstable angina pectoris,
myocardial infarction within 6 months before the first administration of trial drug,
or arrhythmia requiring treatment at the time of screening
13. At screening, QTc interval: male > 450ms, female > 460ms
14. Patients with a history of orthostatic hypotension, or those with SBP = 20mmhg or DBP
= 10mmhg at screening (visit 1) and baseline (visit 2) when switching from supine
position to upright position for 1 or 3 minutes; or those with SBP < 105mmhg at visit
1 and visit 2;
15. Subjects with evidence of impulse control disorder (ICD) during screening (visit 1);
16. A history of suicide attempt (including actual attempt, interruption or failure of
attempt) or suicidal ideation in the past 6 months were defined as those who answered
"yes" to question 4 or question 5 of the Columbia suicide severity rating scale
(c-ssrs) during screening (visit 1);
17. Patients with history of narcolepsy;
18. Those who had a history of alcoholism, drug abuse and drug abuse in the past five
years (visit 1) were screened. Alcoholism was defined as drinking more than 14 units
of alcohol per week (1 unit = 360 ml beer or 45 ml alcohol with 40% alcohol content or
150 ml wine);
19. Patients with malignant tumor within 5 years before screening were excluded from
cervical carcinoma in situ, skin basal cell or squamous cell carcinoma, local prostate
cancer after radical operation and breast intraductal carcinoma in situ after radical
operation;
20. Pregnant or lactating women;
21. The patients who had participated in the rotigotine test were intolerable or
ineffective;
22. Allergic constitution (allergic to two or more drugs or foods) or known to be allergic
to rotigotine or rotigotine microspheres;
23. Those who have participated in clinical trials of other drugs within 3 months before
screening;
24. Other clinically significant medical status, mental status or laboratory abnormalities
judged by the researcher may interfere with the subject's ability to participate in
the study.
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