An Initial Clinical Study to Treat Postictal Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Postictal blood flow
研究概览
简要总结
This study will evaluate the effect of ibuprofen or nifedipine on post-seizure hypoperfusion and neurological deficits in patients with epilepsy. One group will receive ibuprofen, another will receive nifedipine, and anther placebo.
详细描述
Immediately following seizures, brain blood flow is significantly reduced for approximately one hour and is located to the brain area where the seizure originated. This may contribute to symptoms that patients experience immediately following seizures and in between seizures.
Animal studies have shown that that giving anti-inflammatory drugs (e.g., ibuprofen) and blood pressure medications (e.g., nifedipine) prevents the hypoperfusion and behavioural impairments seen in animals immediately following seizures. Thus, two classes of inexpensive and well-tolerated drugs - already in clinical use - have been identified that can be tested in humans to prevent the serious consequences that follow seizures.
The investigators will study 90 subjects admitted to hospital for epilepsy investigations. The investigators will randomly divide the patients into three treatment groups (30 patients each). Patients will receive either placebo, ibuprofen, or nifedipine while in hospital. The effect of each of these treatments on the severity of hypoperfusion and neurological deficits that follows seizures will then be assessed.
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)
盲法说明
The UofC Clinical Research Unit, which has no contact with patients or clinicians, will prepare the concealed randomization schedule and the randomization tool. Our research pharmacy will prepare three identical tablets to be given to each subject. The participant, care provider, investigators, and outcomes assessors will be blinded to treatment
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 16 yrs, frequent seizures (>1 per week) and cognitive ability sufficient to complete neuropsychological testing.
排除标准
- •multiple seizure onset zones, contraindications to CT or MR imaging, any contraindication to ibuprofen or nifedipine, as well as current or recent (< 2 months) exposure COX-2 inhibitor or calcium channel blocker.
研究组 & 干预措施
Placebo
Patients will receive placebo for at least five days prior to the first blood flow study. They will continue to receive placebo until the baseline study is obtained after the postictal study has been completed.
干预措施: Placebo (Drug)
Ibuprofen
Patients will receive ibuprofen 400 mg by mouth three times a day (po tid) for at least five days prior to the first blood flow study. They will continue to receive ibuprofen until the baseline study is obtained after the postictal study has been completed.
干预措施: Ibuprofen (Drug)
Nifedipine
Patients will receive nifedipine 10 mg po tid for 2 days, then 20 mg po tid, thereafter for at least five days prior to the first blood flow study. They will continue to receive nifedipine until the baseline study is obtained after the postictal study has been completed.
干预措施: Nifedipine (Drug)
结局指标
主要结局
Postictal blood flow
时间窗: 5 - 40 days
Change in cerebral blood flow following seizures, relative to baseline. It will be measured by CT perfusion or ASL MRI.
次要结局
- Stress and Self-Efficacy Relationships(5 - 40 days)
- Neuropsychological performance - Picture Sequence Memory Test(5 - 40 days)
- Neuropsychological performance - Flanker Inhibitory Control and Attention Test(5 - 40 days)
- Neuropsychological performance - List Sorting Working Memory Test(5 - 40 days)
- Neuropsychological performance - Picture Vocabulary Test(5 - 40 days)
- Neuropsychological performance- Oral Reading Recognition Test(5 - 40 days)
- Neuropsychological performance - Dimensional Change Card Sort Test(5 - 40 days)
- Neuropsychological performance - Pattern Comparison Processing Speed Test(5 - 40 days)
- Psychological well-being(5 - 40 days)
- Social Relationships(5 - 40 days)
- Negative affect(5 - 40 days)