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临床试验/JPRN-jRCTs051180098
JPRN-jRCTs051180098已完成2 期

A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease

Ito Hidefumi0 个研究点目标入组 120 人开始时间: 2019年3月6日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
120

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
>= 55age old 至 < 80age old(—)
性别
All

入选标准

  • (1) Those who are at age between 55 and 79 years.
  • (2) The patients should be within 3 years after the onset of motor symptoms.
  • (3) The patients should be treated with levodopa/DCI within 3 months and with levodopa/DCI exclusively 28 days right before starting the trial.
  • (4) The dose of levodopa/DCI should be taken from 150mg/day to 300mg/day.
  • (5) The participant's score of MMSE should be 25 or higher.
  • (6) The patient should be judged by attendant doctor to be appropriate for registration.
  • (7) The agreement with the study should be obtained by the document.

排除标准

  • (1) Those who had been treated with the anti-parkinsonian drugs except levodopa/DCI for more than 1month.
  • (2) Those who are in pregnancy, or possible to be pregnant or those who are in the breast-feeding.
  • (3) Those who have taken antidepressant and/or anti-psychotic drugs.
  • (4) Those who have a history of stroke and cerebrovascular disorders.
  • (5) Those who had a history of epilepsy or those who are in treatment of epilepsy.
  • (6) Those who have a history of alcohol intoxication, or have the treatment for alcoholic abuse.
  • (7) Those who have severe comorbidity (liver dysfunction, renal dysfunction and endocrinological disorders).
  • (8) Those who have a familial history of Parkinson's disease.
  • (9) Those who have a history of allergic reaction with 123I-ioflupane.

研究者

发起方
Ito Hidefumi

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