Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
研究概览
详细说明
The efficacy and safety of long-term treatment with pramipexole (BI Sifrol®) were evaluated in Parkinson disease patients in an open-label non-controlled design. The treatment was initiated at 0.125 mg bid (after breakfast and supper).
The dose was increased stepwise with due caution regarding the symptoms and safety of each patient, up to 1.5 mg tid (after each meal). The treatment period was set at 56 weeks, followed by a stepwise dosedecreasing period (maximum 4 weeks).
Study Hypothesis:
Comparison(s):
研究类型
注册
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)
(1) Patients meeting all of the following inclusion criteria
- Patients of at least 20 years of age
- In- or outpatients of either sex.
- Patients in any stage on the modified Hoehn and Yahr severity scale
Exclusion Criteria:
- Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour.
- Patients with subjective symptoms derived from orthostatic hypotension.
- Patients with hypotension (systolic blood pressure <100 mmHg)
- Patients with concomitant illness such as severe cardiac, renal, and hepatic disease
- Patients with a current or past history of epilepsy
- Pregnant, possibly pregnant, or lactating women
- Patients receiving any other investigational products or who have received any other investigational product within 6 months of the study.
- Patients who judged incompetent to give consent
- Others judged by the investigator or co-investigator to be ineligible as subjects.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
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UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score
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次要结果测量
结果测量 |
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UPDRS Part I (mentation, behaviour and mood) total score UPDRS Part IV (complications of therapy) total score UPDRS Part I-III total score UPDRS Part I-IV total score Modified Hoehn and Yahr scale score Global impression of efficacy
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合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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