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临床试验/NCT00286897
NCT00286897已完成3 期

A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

Eisai Limited214 个研究点 分布在 8 个国家目标入组 702 人开始时间: 2006年2月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Eisai Limited
入组人数
702
试验地点
214
主要终点
Patient diaries: Change from baseline to final efficacy visit in the mean total daily OFF time (hr).

研究概览

简要总结

Patients will be randomised to receive either placebo or the study drug for a period of 30 weeks, in addition to their standard Parkinsonian medications. During the first 8 weeks, the patient's levodopa doses may be adjusted if necessary by the investigator. For the remainder of the 22 weeks, all medications should be kept stable. Patients will be required to attend the clinic twice during the screening period and then a further 8 times during the treatment period. They will be required to complete home diaries where they will record their motor function. In addition, their doctor will assess their Parkinson's disease during the clinic visits. There will also be blood draws for safety and pharmacokinetic and pharmacogenomics evaluation. Following the treatment and assessment period, they will return to the clinic one month later for follow up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Patient diaries: Change from baseline to final efficacy visit in the mean total daily OFF time (hr).

次要结局

  • Change from baseline on average OFF time over total treatment period; UPDRS Part II: OFF state; UPDRS Part III: ON state; change from baseline to final efficacy visit in mean total daily ON time w/o dyskinesias or with no troublesome dyskinesias.

研究者

发起方
Eisai Limited
申办方类型
Industry

研究点 (214)

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