NCT05029960终止1 期
Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety of Brivaracetam
研究概览
简要总结
The purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors.
详细描述
In this study, subjects will receive usual treatment for their brain tumor. In addition, they will be given brivaracetam at a dose of 50 mg twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor
- •Patients must be able to provide informed consent
排除标准
- •A pre-existing seizure disorder or epilepsy syndrome prior to tumor diagnosis
- •Active maintenance therapy with an antiepileptic seizure drug (AED) prior to diagnosis of tumor
- •Patients who have experienced an epileptic seizure as the presenting symptom of their brain tumor
- •Predicted life expectancy of less than 6 months from the time of screening
- •Pregnancy
- •Patients with clinically significant hepatic disease (elevated aminotransferases [bilirubin, alkaline phosphatase] > 3 times upper limit normal)
- •Patients with stage 4 or greater renal disease (GFR <30 mL/min/1.73 m2)
- •Patients who are unable to swallow a tablet
- •Patients with active suicidal ideation or a history of suicide attempt or other serious psychiatric disorder having required hospitalization within the previous 2 years.
研究组 & 干预措施
Experimental
Experimental
Brivaracetam at a dose of 50 mg twice daily for 6 months
干预措施: Brivaracetam (Drug)
结局指标
主要结局
Safety of Brivaracetam
时间窗: 6 Months
Evaluate adverse events
次要结局
- Voluntariness for study participation(6 Months)
研究者
Thomas Wychowski
Associate Professor - Department of Neurology , Epilepsy (SMD)
University of Rochester
研究点 (1)
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