NCT01331109终止2 期
A Multicenter, Open-label, 52-Week Extension Study to Evaluate the Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Forest Laboratories31 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 57
- 试验地点
- 31
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have completed or discontinued prematurely from lead-in study, MLN-MD-14, tolerating a minimum daily dose of 50mg milnacipran
排除标准
- •Can not tolerate a minimum daily dose of 50mg milnacipran
- •Significant risk of suicidality
- •Pregnant or breastfeeding
研究组 & 干预措施
Milnacipran
Experimental
oral administration, twice daily dosing
干预措施: Milnacipran (Drug)
结局指标
主要结局
Adverse Events
时间窗: Baseline (Visit 1) to Week 53 (Visit 9)
Number of Patients who experience one or more treatment emergent adverse event (TEAE)
次要结局
未报告次要终点
研究者
研究点 (31)
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