NCT03220256Unknown2 期
Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients: A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Skin rash incidence rate
研究概览
简要总结
The investigators intend to find a way to lower drug rash occurrence by applying drug tolerance induction protocol at the beginning of lamotrigine administration.
Genotyping of participants with rash and those without rash after taking lamotrigine and genetic testing to find common gene mutations in these participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-85 years old
- •Epilepsy patients
- •Patients who started Lamotrigine first time
排除标准
- •Those who do not agree with prior consent
- •Women taking oral contraceptives.
- •history of drug rash
- •Taking enzyme-inducing antiepileptic drugs (EIAED) or valproate (VPA)
研究组 & 干预措施
Lamotrigine tolerance
Experimental
The dose of lamotrigine (0.1mg) started to increase and gradually increased according to the drug tolerance induction protocol, and the efficacy was evaluated by dosing to the commercial capacity (100mg bid) within 2 weeks.
干预措施: Lamotrigine (Drug)
结局指标
主要结局
Skin rash incidence rate
时间窗: 2 weeks
次要结局
- Lamotrigine drug level in blood (mcg/ml)(2 weeks)
- Severity of skin rash (CTCAE version 4.0)(2 weeks)
- Changes in Treg cell ratio in peripheral blood(2 weeks)
研究者
Sang Kun Lee
Professor
Seoul National University Hospital
研究点 (1)
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