Evaluating Efficacy and Tolerability of Three Times Daily Levetiracetam in Epilepsy Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- change in mean number of Seizure-free days
研究概览
简要总结
The purpose of this clinical trial is to evaluate the efficacy and tolerability of Levetiracetam administered three times daily in patients with epilepsy. The primary objective is to investigate whether orally administered Levetiracetam three times daily dosing is superior in seizure-free days compared to standard twice-daily dosing in patients with epilepsy.
Key questions include:
- Does LEV improve seizure control, as measured by seizure-free days?
- What adverse events or safety concerns are observed with LEV treatment?
Participants will receive Levetiracetam administered three times daily during the treatment phase. The study will use a self-matched, pre-post design in which each participant serves as their own control. Baseline seizure activity and safety data will be collected prior to LEV initiation and compared with data obtained during the treatment period. Participants will attend scheduled clinic visits for efficacy and safety evaluations and will maintain a daily diary to record seizure frequency and any treatment-related events.
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
- •Aged 18 years or older.
- •diagnosed with uncontrolled Epilepsy of any type (defined as one or more unprovoked seizures in the last 6 months)
- •On Levetiracetam monotherapy
- •Participants must have a documented history of Levetiracetam use for at least 12 months prior to enrollment.
- •on Levetiracetam high dose (1.5 - 3 g daily)
排除标准
- •Younger than Aged 18 years
- •Received Levetiracetam intravenous within the last 24hr.
- •Co-administered with other antiepileptic drugs
- •Received other antiepileptic drugs in the last two weeks.
- •Pregnant women.
- •Renal impairment (Crcl < 30) or Acute kidney injury
结局指标
主要结局
change in mean number of Seizure-free days
时间窗: within 6 months pre and post interventions
The mean number of seizure-free days (unit: days), defined as calendar days without any reported seizure events, will be measured and compared in patients with epilepsy during treatment with Levetiracetam administered three times daily versus twice daily (self-controlled comparison). Seizure-free days will be assessed using a patient-reported seizure diary (standardized daily seizure log)
次要结局
- % Adverse events(12 month post interventions)
研究者
Waad Alkathiri
Clinical Pharmacist
King Saud University