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.
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