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临床试验/JPRN-jRCT2080221909
JPRN-jRCT2080221909未知3 期

Randomized, double-blind, placebo-controlled study on FPF1100NW monotherapy with early Parkinson's disease patients (Phase III study)

FP Pharmaceutical Corp.0 个研究点目标入组 280 人开始时间: 2012年9月6日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
280

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

年龄范围
>= 20age old 至 <= 74age old(—)
性别
All

入选标准

  • Main inclusion criteria
  • Parkinson's disease patients who have no history of previous treatment with anti-Parkinson's disease drugs
  • Within five years after onset of motor symptoms
  • Modified Hoehn & Yahr rating stage I - III
  • UPDRS part III total score 10 or greater

排除标准

  • Main exclusion criteria
  • Patients taking the drugs designated in the exclusion criteria during a certain period of time before starting administration of the investigational drug
  • Patients complicated with serious neurological and mental disorders (e.g. disturbed consciousness, hallucination, delusion, abnormal behaviors, etc.)
  • Patients under epilepsy treatment
  • Patients with advanced complications in the cardiovascular system, liver, kidney, blood or other organs
  • Patients with complication or history of schizophrenia
  • Patients with dependence on CNS stimulants (e.g. amphetamines, cocaine, etc.) or with such history
  • Patients during pregnancy or lactation, or patients who wish to get pregnant during the study
  • Patients who participated in any study using selegiline in the past

研究者

发起方
FP Pharmaceutical Corp.

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