Clinical Study of Stalevo in the Treatment of Early Parkinson's Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The occurrence and frequency of dyskinesia of participants in two groups were assessed by blind method.
研究概览
简要总结
The main goal of PD research is to develop disease-modifying drugs to delay or prevent the underlying neurodegenerative process. Levodopa, as the gold standard for PD treatment, is associated with the occurrence of motor complications. Many previous studies have confirmed that Stalevo can reduce the side effects of levodopa alone. Moreover, the effects of Stalevo on the treatment of PD patients have been extensively studied, but the efficacy of Stalevo in early PD patients has been less studied. Therefore, it is necessary to further study the treatment of early PD with Stalevo, and observe whether increasing the number of medication can reduce the occurrence of dyskinesis. The research results will help to deepen the understanding of Stalevo in the treatment of early PD and its clinical efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in the trial and sign the informed consent
- •The enrolled patients were 30 to 70 years old, diagnosed as primary Parkinson's disease according to the 2015 MDS Parkinson's disease diagnostic criteria, H-Y grade <3, and the onset time was less than 5 years
- •Patients can take stable dopamine receptor agonists or other anti-Parkinson's disease drugs (drugs have not been adjusted in the past 4 weeks), and have not used amantadine or entacapone within 1 year.
排除标准
- •Atypical Parkinsonism and Secondary parkinsonism
研究组 & 干预措施
Stalevo group
Stalevo is taken five times a day, three hours apart. Compare the incidence of dyskinesia.
干预措施: Stalevo (Drug)
Control group
Carbidopa and Levodopa Sustained-release Tablets is taken five times a day, three hours apart. Compare the incidence of dyskinesia.
干预措施: Carbidopa and Levodopa Controlled Release Tablets (Drug)
结局指标
主要结局
The occurrence and frequency of dyskinesia of participants in two groups were assessed by blind method.
时间窗: 1 year
The duration of the study is 96 weeks. Follow-up: Baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks, 96 weeks. At each visit, the doctor performs a blind assessment of dyskinesia. The proportion of patients with no dyskinesias in the two groups at each visit was recorded. The Kaplan-Meier line was used to analyze the relationship between the drug and the occurrence of dyskinesia.
The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) of participants in two groups were assessed by blind method.
时间窗: 1 year
At each visit, the patient completed the MDS-UPDRS. The doctor performs a blind assessment of MDS-UPDRS parts II, III, and IV. MDS-UPDRS part II, Motor Experiences of Daily Living (13 items); part III, Motor Examination (33 items); and part IV, Motor Complications. (6 items). All items have five response options with uniform anchors of 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The more severe the symptoms, the higher the score.
The 9-Item Wearing-Off Questionnaire （WOQ-9） score of participants in two groups were assessed by blind method.
时间窗: 1 year
During the double-blind period, subjects completed WOQ-9 at each visit. WOQ-9 was used to assess symptoms of wearing-off. The nine symptoms include tremor, anxiety, mood changes, slowness of movement, reduced dexterity, general stiffness, pain/aching, slowness of thinking , and muscle cramping. The presence of one of these symptoms and relief after the next dose is indicative of wearing-off.
次要结局
未报告次要终点