A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the objective weight of saliva in patients with Parkinson's disease changed from baseline
研究概览
简要总结
Objective: To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson's disease Study content: Using a randomized, double-blind, placebo-controlled study design, 120 patients with Parkinson's disease and cognitive impairment were enrolled, and the treatment was followed up for 12 weeks: dihydroergotine mesylate sustained-release tablets + conventional treatment (treatment group patients, 80 cases), placebo + conventional treatment (control group patients, 40 cases), and the main indicators were observed: the improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was observed, and the secondary indicators were observed: the effect of dihydroergotine mesylate sustained-release tablets on the cognitive function of PD patients was observed.
Expected results: The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group. The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients.
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
- Double (Participant, Investigator)
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 with Parkinson's disease diagnosed by the British Parkinson's Disease Brain Bank Diagnostic Criteria can come to the hospital accompanied by family members
- •drooling score using the Parkinson's Comprehensive Rating Scale (UPDRS) Part II (Item 6) ≥3;
- •MMSE ≥ 10 points (recording the patient's education level)
- •Adults over the age of 18
- •The applicant or his/her caregiver must be able to complete the record of the salivation score
- •Patients or family members voluntarily participate and sign an informed consent form.
排除标准
- •Patients with non-primary Parkinson's disease
- •Known allergy to dihydroergotamine mesylate
- •Drug-induced hypersalivation, such as olanzapine, antipsychotics, clonazepam and other antiepileptic drugs, as well as direct and indirect cholinergic agonists for the treatment of Alzheimer's disease and myasthenia gravis
- •BoNT treatment for saliva within the previous 3 months
- •Patients with symptomatic bradycardia, severe orthostatic hypotension, symptomatic coronary insufficiency, severe organic cardiac damage, severe liver and kidney insufficiency: including ALT≥2.5ULN (upper limit of normal value of the executive laboratory); AST≥2.5ULN (upper limit of normal for the execution laboratory); Creatinine ≥ 1.5 ULN (upper limit of normal at the execution laboratory), active psychosis, pregnancy/pregnant woman
研究组 & 干预措施
Placebo Comparator: placebo
control group patients, 40 cases
干预措施: Placebo (Drug)
Experimental: dihydroergotine mesylate sustained-release tablets
treatment group patients, 80 cases
干预措施: dihydroergotine mesylate sustained-release tablets (Drug)
结局指标
主要结局
the objective weight of saliva in patients with Parkinson's disease changed from baseline
时间窗: the objective weight of saliva in patients with Parkinson's disease changed from baseline at the 4th, 8th and 12th weeks
次要结局
未报告次要终点