Neupro's Multicenter and Prospective Observation of Safety and Efficacy in Chinese Mainland Idiopathic Parkinson's Disease in Real World Practice
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- (serious) adverse events (AE) and (serious) adverse drug reactions (ADRs)
研究概览
简要总结
This is a multicenter, prospective, non intervention post marketing surveillance study conducted in Chinese mainland. The main objective was to evaluate the safety characteristics of rotigotine patch in the treatment of Chinese adult patients with idiopathic Parkinson's disease in real world clinical practice.
详细描述
Parkinson's disease (PD) is a long-term, chronic, progressive and disabling disease, which affects millions of patients worldwide. The incidence rate of Parkinson's disease is about 20/100000 per year. With the increase of age (65 years old and above), the incidence rate of the population increased significantly, reaching >100/100000 per year . The average age of onset is 58 to 62 years old, and the prevalence rate of people over 50 years old is about 1%. Similar to the incidence rate, the prevalence of Parkinson's disease increases with age. It is 1.4% at 55 years old, and 4.3% in 85 years old and above.
The main clinical symptoms of Parkinson's disease include tremor, myotonia, motor retardation, postural reflex disorders and gait disorders, as well as a variety of other motor, mental, sensory and autonomic neuropathy. Depressive symptoms of Parkinson's disease are very common in patients. In the progressive stage of the disease, patients may have dementia symptoms. Autonomic nervous system involvement may cause orthostatic hypotension, paroxysmal flushing, thermoregulation disorders, constipation, dysphagia, bladder and sexual dysfunction. Involvement of dopaminergic pathways in the thalamus and spinal cord may lead to sensory abnormalities.
The etiology of Parkinson's disease remains unclear. However, it is generally considered to be a progressive degenerative disease, which gradually erodes the brain stem, basal ganglia structure and its projection system. Pathological studies have found that there are loss of dopaminergic neurons in substantia nigra and neurons in locus coeruleus and raphe nucleus, deposition of Lewy bodies and activation of glial cells. Basic studies suggest that oxidative damage of specific neurons in basal ganglia is one of the potential causes of idiopathic Parkinson's disease, and aging and genetic factors are also the main causes of the disease
Predisposing factors.
Rotigotine ((6S) - 6 - {propyl [2 - (2-thienyl) ethyl] amino} - 5,6,7,8-tetrahydro-1-naphthol) is the left-handed enantiomer of chiral aminotetrahydronaphthalene compounds. Rotigotine is a dopamine receptor agonist. Its dosage form is designed as a transdermal drug delivery system, which can continuously release rotigotine within 24 hours. Transdermal drug delivery system, which continuously releases dopamine receptor agonists (such as rotigotine) in a non-invasive manner. Rotigotine has been approved by global health agencies for the treatment of early and advanced Parkinson's disease. Overall, ushib or authorized partners have market licenses for rotigotine transdermal patches for Parkinson's disease in 70 countries. A detailed description of the preclinical and clinical experience of rotigotine can be found in the investigator's manual.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet the following selection criteria to enter the non intervention study:
- •The decision of the treatment doctor to prescribe rotigotine patch has nothing to do with whether to participate in the non intervention study.
- •The patient or his legal representative can understand the informed consent of the patient data.
- •The informed consent form of patient data shall be signed and dated by the patient or his legal representative.
- •The patient is over 18 years old.
- •The patient was diagnosed as idiopathic Parkinson's disease
排除标准
- •Patients meeting any of the following criteria should be excluded from the study:
- •For any reason, the researcher (therapist) thinks that the patient is not suitable to participate in this study.
- •Patients had received rotigotine patch for more than 4 weeks before study enrollment.
研究组 & 干预措施
Neupro gruop
Patients using Neupro according to the standard clinical practice of therapists
干预措施: Neupro (Drug)
结局指标
主要结局
(serious) adverse events (AE) and (serious) adverse drug reactions (ADRs)
时间窗: in 12 weeks
(serious) adverse events (AE) and (serious) adverse drug reactions (ADRs)
次要结局
未报告次要终点
