EUCTR2005-002134-35-DE进行中（未招募）1 期
EXTENSION STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF ESLICARBAZEPINE ACETATE (BIA 2-093) IN THE RECURRENCE PREVENTION OF BIPOLAR I DISORDER
BIAL - Portela & Cª, SA0 个研究点目标入组 160 人开始时间: 2005年10月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Informed consent form signed; completed the 3-week treatment period in Protocol SCO/BIA-2093-203 or Protocol PRA/BIA-2093-204 and shown response to treatment [i.e., = 50% improvement in the Young Mania Rating Scale (YMRS) total score or an YMRS total score < 12]; in case of woman of childbearing potential, patient presents a serum pregnancy test consistent with a non-gravid state and will use double-barrier contraception throughout the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Relevant ECG or laboratory abnormalities; any uncontrolled clinically relevant disorder; not ensured capability to comply with the study protocol.
研究者
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