A Randomized, Double-Blind Placebo Controlled, Parallel Groups Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by MRI

Merck Sharp & Dohme LLC0 个研究点目标入组 120 人开始时间: 2004年8月最近更新: 2016年8月1日

适应症

试验速览

阶段: 2 期
状态: 终止
发起方: Merck Sharp & Dohme LLC
入组人数: 120
主要终点: Accrual rate of new GD-enhancing lesions as assessed by MRI

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to test MK0812 on disease activity in patients with relapsing-remitting MS. Disease modifying activity will be assessed by measurement of brain lesions via MRI brain scans and an open label extension is offered.

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: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients must have clinically definite relapsing-remitting MS onset within last 10 years and have had at least 1 objective clinical exacerbation in the last year OR a recent clinically isolated syndrome suggestive of MS occurring 3-12 months before screening
•Patients must be relatively healthy

排除标准

•Patient has primary progressive MS

结局指标

主要结局

Accrual rate of new GD-enhancing lesions as assessed by MRI

时间窗: 3 Months

次要结局

Volume and cumulative number of new persistent Gd-enhancing lesions(3 Months)

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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