A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis

UCB Pharma1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2005年1月最近更新: 2013年8月30日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: UCB Pharma
入组人数: 60
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

This was a multicenter, open-label, randomized, crossover trial in subjects with MS who were already taking a stable dose of baclofen (up to 80 mg/day) for spasticity. The trial was designed to assess subject preference for Kemstro or conventional baclofen. At Visit 1, subjects were screened, and if qualified, were randomly assigned to one of two following treatment sequences: Kemstro/conventional baclofen or conventional baclofen/Kemstro.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•stable dose of baclofen

排除标准

•not stable dosing

研究者

发起方

UCB Pharma

申办方类型

Industry

研究点 (1)

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