Clinical Study Evaluating and Comparing the Safety and the Possible Efficacy of Pentoxifylline and Celecoxib in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The clinical outcome will be assessed through Quality of Life questionnaire (QOLIE-31)
研究概览
简要总结
Epilepsy is a chronic neurological disorder affecting millions of people all over the world. Epileptic seizures are caused by abnormal synchronized electrical neuronal discharges that could be either focal or widespread. Pathogenesis of epilepsy involves multiple processes including genetics, oxidative stress, ion channels, neuroinflammation, and cellular damage through autophagy and apoptosis.
Neuroinflammation is considered one of the most important factors contributing critically to epileptogenesis.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
double-blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years old. Patients with grand mal epilepsy on phenytoin monotherapy. Women with a negative pregnancy test and women on effective contraception
排除标准
- •Patients with significant liver and kidney function abnormalities. Alcohol and/or drug abusers. Patients with known allergies to the study medications Patients with known allergy to sulfonamides (cross hypersensitivity with celecoxib).
- •Pregnant women and women with a planned pregnancy. Subjects on medication are known to have possible positive effects on epilepsy. Patients who are currently using other antiepileptic drugs. Patients with CVD and a history of coronary artery bypass graft (CABG) surgery. Patients on aspirin or fluconazole therapy Patients with a recent retinal or cerebral hemorrhage
研究组 & 干预措施
Control Group
This group will receive 100 mg of phenytoin 3 times daily for 6 months.
干预措施: Phenytoin (Drug)
Pentoxifylline group
This group will receive 100 mg of phenytoin 3 times daily plus pentoxifylline 400 mg two times daily for 6 months
干预措施: Phenytoin (Drug)
Pentoxifylline group
This group will receive 100 mg of phenytoin 3 times daily plus pentoxifylline 400 mg two times daily for 6 months
干预措施: Pentoxifylline 400 MG (Drug)
Celecoxib group
This group will receive 100 mg of phenytoin 3 times daily plus celecoxib 200 mg once daily for 6 months
干预措施: Phenytoin (Drug)
Celecoxib group
This group will receive 100 mg of phenytoin 3 times daily plus celecoxib 200 mg once daily for 6 months
干预措施: Celecoxib 200mg (Drug)
结局指标
主要结局
The clinical outcome will be assessed through Quality of Life questionnaire (QOLIE-31)
时间窗: 6 months
Caregivers will complete the questionnaire for assessing the quality of life in epileptic patients.
次要结局
- The secondary outcome is the change in the serum level of the measured biological parameters(6 months)
研究者
Mostafa Bahaa
Teaching Assistant
Tanta University