NCT00056524已完成3 期
An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.
Avanir Pharmaceuticals75 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2003年2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
- 600
- 试验地点
- 75
- 主要终点
- emotional control
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of AVP-923 in the treatment of Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes of uncontrolled crying and/or laughter).
详细描述
This is an "open label" study which means there is no placebo group. Each subject enrolled into the study will receive AVP-923.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years of age, inclusive
- •Clinical diagnosis of PBA (pseudobulbar affect)
- •If female, must not be pregnant or breast feeding
排除标准
- •Sensitivity to quinidine or any opiate drugs
- •Current or prior history of major psychiatric disturbance
- •Currently participated in a trial within the past 30 days
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 (75)
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