Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Six Month Seizure Freedom
研究概览
简要总结
This is a study to determine whether a combination of low dose lacosamide and levetiracetam is more effective than high dose levetiracetam in patients who have failed low dose levetiracetam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Adults age 18 or older
- •Determined to have had at least two partial seizures by an epilepsy specialist, or to have had a single partial seizure with clinical and/or laboratory evidence of a high seizure recurrence risk
- •Monotherapy on levetiracetam less than or equal to 1500 mg/day for at least two weeks
- •Breakthrough seizure while on stable dose (>5 days) of levetiracetam monotherapy regimen, not due to provocative factors (e.g. hypoglycemia, head trauma, missed medications)
排除标准
- •Clinical suspicion of nonepileptic psychogenic seizures or idiopathic generalized epilepsy
- •Pregnant, child-bearing age not using contraception, or breast feeding
- •Medical contraindication to adding lacosamide
- •History of antiepileptic drug (AED) polytherapy
- •Presence of a vagus nerve stimulator
- •Creatinine clearance of less than 50 mL/min
- •Blood pressure instability: pulse <50 or >100, systolic blood pressure (SBP) <50 or >180, clinically significant electrocardiogram (EKG) abnormality
- •History of significant drug rash or anaphylactic reaction with antiepileptic drug
- •Patients with progressive lesions (e.g. brain tumors)
研究组 & 干预措施
Lacosamide + Low-Dose Levetiracetam
Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
干预措施: lacosamide (Drug)
Control Group (High-Dose Levetiracetam)
Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
干预措施: levetiracetam (Drug)
Lacosamide + Low-Dose Levetiracetam
Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
干预措施: levetiracetam (Drug)
结局指标
主要结局
Percentage of Participants Achieving Six Month Seizure Freedom
时间窗: 6 Months
Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug.
次要结局
- Time to First Seizure After Therapeutic Dose is Reached(6 Months)
- Retention Rate(6 Months)
- Number of Seizure-Free Days(6 Months)
- Number of Participants With Treatment-Emergent Adverse Events (TEAE)(6 Months)
研究者
Jong Woo Lee
Associate Neurologist
Brigham and Women's Hospital