NCT00274131已完成3 期
Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 170
- 主要终点
- UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score
研究概览
简要总结
To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study).
详细描述
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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •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
排除标准
- •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.
结局指标
主要结局
UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score
次要结局
- 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
研究者
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