NCT00050232已完成3 期
Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients
Avanir Pharmaceuticals39 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2002年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 39
- 主要终点
- emotional control
研究概览
简要总结
Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying out of proportion. Other terms used to describe this condition include emotional lability, emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923 in the treatment of MS patients suffering from pseudobulbar affect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 68 years of age
- •Confirmed diagnosis of Multiple Sclerosis
- •Clinical history of pseudobulbar affect
排除标准
- •Sensitivity to quinidine or opiate drugs
- •Recent diagnosed within 2 months with Multiple Sclerosis
- •Patient on anti-depressants
- •Patient with liver or kidney disease
- •Patient with hypotension
结局指标
主要结局
emotional control
次要结局
未报告次要终点
研究者
研究点 (39)
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