EUCTR2020-004878-22-FR进行中（未招募）1 期
Pharmacokinetic and Placental Transfer of Levetiracetam - EPICEINTE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- Female
入选标准
- •- Pregnant women of childbearing age who are pregnant
- •- Age =18 years
- •- Women with epilepsy treated with levetiracetam in monotherapy or combination
- •- Affiliated to a social security scheme (or entitled)
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Women treated with antiepileptics for pathology other than epilepsy
- •- Women treated with a combination of more than 3 antiepileptics
- •- Severe anemia
- •- Renal failure (moderate to severe)
- •- Hepatic impairment (moderate to severe)
- •- Alcohol and/or recreational drug use
- •- Trend towards non-compliance with treatment
- •- Inability to maintain a Crisis Observation Workbook
- •- Suicidal Ideas
- •- Uncontrolled thyroid disease
- •- Woman under tutorship or curatorship
- •- Patient under state medical assistance (AME)
研究者
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