NCT02231905已完成4 期
Open Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to Pramipexole
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Number of patients who prematurely discontinued due to adverse event
研究概览
简要总结
Study to assess the safety, tolerability and effectiveness of a switching from Domin® (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease (included juvenile parkinsonism) and treated with talipexole (Domin®)
- •Patients who present stable symptoms and maintain the doses of talipexole and other concomitant therapy for Parkinson's disease at least last 4 weeks
- •Male or female patients aged 20 and over
- •In or out-patients
- •Patient's severity characterized as Stage 1 - 5 by Modified Hoehn & Yahr scale
- •Ability to provide written informed consent in accordance with the Good Clinical Practice (GCP), Good Post-marketing Surveillance Practice (GPMSP) and other relevant laws such as the Pharmaceutical Affairs Law
排除标准
- •History of hypersensitivity of pramipexole
- •Psychiatric symptoms such as confusion, hallucination, delusion, agitation, delirium and abnormal behavior
- •Subjective symptom derived from orthostatic hypotension
- •Hypotension (systolic blood pressure; 100 mmHg or less)
- •Complication such as clinically significant cardiac, renal and hepatic diseases
- •Patients who drive a car, operate a machine, work on heights or engage in other hazardous activities
- •Pregnant, possibly pregnant or female in lactation
- •Patients who are participating in other drug studies or who receive other investigational drugs within last 3 months before enrolled this study
- •Other than above, those who judged by the investigator or sub-investigator to be inappropriate as for the study
研究组 & 干预措施
BI-Sifrol®
Experimental
Tablets were administrated after switching from prior treatment of dopamine agonist (talipexole), treatment period consisted of an ascending period and a maintenance period, total duration was 4 to 12 weeks.
干预措施: BI-Sifrol® (Drug)
结局指标
主要结局
Number of patients who prematurely discontinued due to adverse event
时间窗: up to 12 weeks
次要结局
- Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)(up to 12 weeks)
- Change of the sum of UPDRS Part III (motor examination)(up to 12 weeks)
- Change of Modified Hoehn & Yahr scale(up to 12 weeks)
- Change of Clinical global impression (CGI) of efficacy(up to 12 weeks)
- Number of patients with abnormal changes in laboratory parameters(up to 12 weeks)
- Number of patients with clinically significant changes in vital signs(up to 12 weeks)
- Number of patients with adverse events(up to 12 weeks)
- Number of patients with clinically significant changes in electrocardiogram (ECG)(up to 12 weeks)
研究者
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