CTRI/2009/091/001069已完成3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson's Disease
SCHWARZ BIOSCIENCES, Inc.8010 Arco Corporate Drive, Suite 100 Raleigh, NC 27617, USA0 个研究点目标入组 500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Parkinson's Disease greater than 3 years
- •2.Stable dose L-dopa but symptoms not adequately
- •controlled and have "off" time
- •3.Able and willing to complete diary on specific days
排除标准
- •1.Previous use of rotigotine or Neupro
- •2.Atypical Parkinson's syndrome
- •3.Pallidotomy
- •4.Thalamotomy
- •5.Deep brain stimulation
- •6.Fetal tissue transplant
- •7.Dementia
- •8.Psychosis
- •9.Hallucinations
- •10.Epilepsy
- •11.Renal or hepatic dysfunction
- •12.Clinically relevant cardiac dysfunction
- •13.Symptomatic orthostatic hypotension
- •14.Skin sensitivity to adhesives or unresolved contact
- •15.History of chronic alcohol or drug abuse
- •16.Pregnant or of child-bearing potential
- •17.Impulse control disorder
研究者
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