jRCTs031180248已完成不适用
Intervention study for the effect of Istradefylline on adjustment of Levodopa in Parkinson's Disease (Istra adjust PD)
未提供0 个研究点目标入组 111 人开始时间: 2019年5月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 30age old over 至 84age old under（—）
- 性别
- All
入选标准
- •Current use of levodopa-containing drugs more than
- •300mg/day and less than 400mg/day administered at least
- •three times daily
- •Patients with wearing-off
- •>= 30 to < 85 years of age at the time of registration
- •for the study
- •Diagnosed as Parkinson's disease based on the
- •International Parkinson and Movement Disorder Society
- •Stages <=3 in the ON state for Modified Hoehn and Yahr
- •Patients who have given written consent if the patient
- •has difficulty in writing due to his or her condition,
- •a representative may sign the written consent, subject
- •to the patient's prior oral consent
排除标准
- •Use of Istradefylline in the past
- •Current use of an investigational drug (within 4 months
- •prior to the registration for the study)
- •Patients with dementia or a score of 23 or less on the
- •Mini-Mental State Examination (MMSE)
- •Patients with a previous history of brain surgery for
- •the treatment of Parkinson's disease at the time point
- •of the registration
- •Current use or plan to administer levodopa/carbidopa
- •intestinal gel at the time point of the registration
- •Patients with moderate to severe hepatic disorder
- •Use of a new anti-Parkinson's disease drugs or change
- •in the treatment of anti-Parkinson's disease drugs
- •within 14 days prior to the registration for the study
- •Current use of a strong inhibitor of CYP3A4
- •(Itraconazole, Clarithromycin) within 14days prior to
- •the registration of the study
- •Female patients who are pregnant, trying to become
- •pregnant or nursing (lactating) an infant
- •Patients who are in the Investigator's judgment
- •unlikely to comply with medical regimens or study
- •requirements
结局指标
主要结局
-
Accumulated dose of Levodopa
次要结局
- Additional dose(Week4 until Week36)
- Number of the days to the first additional dose(Week0)
- Change in the dose of levodopa(until Week36)
- CGS-S score
- CGS-I score(from the previous visit)
- PGS-S score
- PGS-I score(from the previous visit)
- Change in modified Hoehn & Yahr scale
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
- Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
- Change in Parkinson's Disease Questionnaire (PDQ)-39 score
- Correlation among the score change presented
- Analysis of the motion, gait, sleeping using wearable device
研究者
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