临床试验/NCT01673724

NCT01673724已完成4 期

Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study

Sandoz7 个研究点分布在 1 个国家目标入组 121 人开始时间: 2012年2月最近更新: 2017年9月15日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Sandoz
入组人数: 121
试验地点: 7
主要终点: K-NMSS

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether pramipexole and bromocriptine are effective in the treatment of non-motor symptoms in Parkinson's Disease.

详细描述

PRIMARY OBJECTIVE Evaluate the Improvement of Nonmotor symptom scale (NMSS) between Pramipexole and Bromocriptine for early Parkinson's disease during 24-week treatment

SECONDARY OBJECTIVE

Evaluate the improvement for Depression which is one of the Nonmotor symptoms
Evaluate the improvement of clinical symptoms between two groups
Evaluate the improvement of Quality of Life between two groups

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Parkinson's disease patients in accordance with UK Queensquare Brain Bank
•modified Hoehn & Yahr stage <3
•Dopamine agents(Levodopa, dopamine agonists) naive patients, or the patients who have discontinued the agents at least four weeks before the screening in case of using the dopamine agents are administered before.

排除标准

•K-MMSE<24
•History of drug-induced Parkinsonism
•secondary parkinsonism
•History of schizophrenia or hallucination
•Requirement of treatment with anti-depressants due to depressive disorder
•Pregnant and/or breeding women
•Renal inadequacy

研究组 & 干预措施

pramipexole

Experimental

dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks

干预措施: pramipexole (Drug)

Bromocriptine

Active Comparator

bromocriptine dosage form: white round tablet

干预措施: Bromocriptine (Drug)

结局指标

主要结局

K-NMSS

时间窗: 24 weeks

Evaluate The total and each category score of K-NMSS

次要结局

UPDRS I/II/III(24 weeks)
K-MADRS(24 weeks)
K-PDQ39(24 weeks)

研究者

发起方

Sandoz

申办方类型

Industry

责任方

Sponsor

研究点 (7)

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