NCT05008354已完成4 期
Investigation of Pyridoxine Effect on Behavioral Adverse Events of Levetiracetam in Adult Patients With Epilepsy
Nasim Tabrizi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Behavioral side effects
研究概览
简要总结
This study is a two-arm parallel group randomized double-blind placebo-controlled trial with the aim of Investigating pyridoxine effect on behavioral side effects of levetiracetam in adult patients with epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years
- •Patients with epilepsy
- •Patients who are treated by levetiracetam (Levebel, Cobel darou) in recent month
- •Complaint of behavioral problem
- •Patient's consent for participation
排除标准
- •History of known psychiatric disease
- •Pregnancy
- •Incidence of psychotic side effects including hallucination, psychosis, suicidal idea or attempt
- •Treatment with psychiatric medications
- •Alcohol or drug abuse
- •Mental retardation to the degree that intervenes comprehension and response to questionnaire
研究组 & 干预措施
Pyridoxine
Active Comparator
干预措施: Pyridoxine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Behavioral side effects
时间窗: 3 weeks
Behavioral side effects are measured by SCL-90-R questionnaire
次要结局
未报告次要终点
研究者
Nasim Tabrizi
Associate professor of neurology
Mazandaran University of Medical Sciences
研究点 (1)
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