Study of Phenobarbital Inhibition of Catamenial Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Addenbrooke's Cognitive Examination (ACE)
研究概览
简要总结
The purpose of this study is to test the effectiveness of low-dose Phenobarbital on the treatment of catamenial epilepsy.
We propose that since the catamenial seizures are associated with the reduction in levels of GABA-enhancing allopregnanolone, short-term replacement with the GABAR-enhancing agent Phenobarbital will reduce the incidence of catamenial seizures.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients seeking medical attention for seizures
- •Regular menstrual cycles
- •At least 2 seizures per month
- •Must be on at least one form of birth control other than abstinence
- •Must be on a stable anticonvulsant regimen of at least one and not exceeding three anticonvulsants, and not be using any perimenstrual seizure medications of hormone preparations
- •If taking benzodiazepines for therapeutic purposes, must be on a stable regular dose
- •Must be willing to take at least 400mcg of folic acid a day while in the study
- •Must be able to detect, count or record seizures
排除标准
- •Can not be pregnant or trying to become pregnant
- •Can not have used hormonal birth control methods for at least 3 months prior to enrollment
- •Can not have an allergy to Phenobarbital
- •Can not have a history of non-epileptic seizures
- •Can not have a know liver dysfunction or history of chronic hepatitis
- •Can not have a history of neurological disorder or history of status epilepticus in the preceding year
- •Can not ahve a physical or psychiatric condition which in the PIs opinion could compromise her ability to participate
研究组 & 干预措施
1
Phenobarbital - dose based by weight range
干预措施: Phenobarbital (Drug)
2
Placebo group
干预措施: Placebo (Other)
结局指标
主要结局
Addenbrooke's Cognitive Examination (ACE)
时间窗: Screening, 3 month and Final Visit
Quality of Life in Epilepsy (QOLIE-10)
时间窗: Screening, 3 month and Final Visit
Patient Health Questionnaire (PHQ-9)
时间窗: Screening, 3 month and final visit
Depression Epworth Sleepiness Scale (ESS)
时间窗: Screening, 3 month and final visit
次要结局
- Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above(Screening, 3 months, final visit)