NCT00195754已完成3 期
The Safety of Divalproex Sodium Extended Release Tablets in Migraine Prophylaxis: An Open-Label Extension Study in Adolescents
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Safety outcome measure
研究概览
简要总结
The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote ER is safe in the reduction of occurrence of migraine headaches in adolescents.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject and subject's legal representative have voluntarily signed and dated an IRB-approved informed assent form and an IRB-approved informed consent form, respectively, before any study-specific procedures or tests are performed;
- •The subject was randomized into Study M02-488 and either completed the study or prematurely discontinued due to ineffectiveness; and
- •The subject is male or non-pregnant, non-lactating female
- •Exclusion Criteria
- •Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives).
- •Experienced a serious adverse event in Study M02-488 which the investigator considered "possibly" or "probably related" to study drug; or
- •In the investigator's opinion, long-term treatment with Depakote ER for migraine prophylaxis is contraindicated.
- •For any reason, subject is considered by the investigator to be an unsuitable candidate to receive divalproex sodium or to participate in this study.
排除标准
- 未提供
结局指标
主要结局
Safety outcome measure
时间窗: 12 months
次要结局
- Migraine headache rate(12 months)
研究者
研究点 (2)
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