Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy: An Open, Prospective, Multicenter, Randomized Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 409
- 试验地点
- 1
- 主要终点
- Rate of seizure-free patients
研究概览
简要总结
The purpose of this study is to compare the efficacy, safety and tolerance of the drugs Lamotrigine and Levetiracetam in the initial monotherapy of patients with newly diagnosed epilepsy.
详细描述
Epilepsy is the second most frequent neurologic disease (prevalence 0.5 % - 1 % [Brodie et al. 1997]). About 30 % of epilepsy patients (including many children) suffer from intractable seizures [Kwan & Brodie 2000]. Therefore new drugs and an expansion of permission for drugs with limited approval, respectively, are needed.
Levetiracetam is a new potent antiepileptic drug with nearly ideal pharmacokinetic properties and few side effects [Patsalos 2000], but it is approved in Germany only for add-on therapy for patients > 15 years of age with focal epilepsy.
Due to its few cognitive side effects and its efficacy, Lamotrigine is becoming standard therapy for focal and generalized epilepsy for patients from >11 years of age. Its disadvantage is the possibility of severe allergic reactions which limits the speed of dose increment.
Comparisons: Patients with newly diagnosed epilepsy are treated with either Lamotrigine or Levetiracetam. Rate of seizure-free patients in the first 6 weeks of the trial (main outcome criterion) as well as rate of seizure-free patients during the last 16 weeks and the total 26 weeks of the observation period, time until the first seizure appears, time patients take the study medication, safety and quality of life during treatment are compared.
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
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 12 years
- •Body weight ≥ 30kg (patients 12-15 years of age) and ≥ 40kg (patients over 16 years of age), respectively
- •Either one epileptic seizure with high risk of relapse (partial seizure semiology, MRI lesion or pathological focal EEG findings) or a newly diagnosed epilepsy (≥ 2 unprovoked seizures) with at least 1 seizure within the past 3 months before begin of trial participance
- •Treatment with no or a maximum of one anticonvulsant drug at the time of inclusion
- •Fertile women of ≥ 16 years of age must use at least one of the following contraceptives for at least one month prior to initiation of trial participance: Oral contraceptive, contraceptive diaphragm, intrauterine contraceptive device (coil), tube ligation. For girls between 12 and 15 years of age a written confirmation of sexual abstinence, given by a person having the care and custody of the child, is sufficient.
- •Informed consent by the proband in written form after being informed about character, relevance and consequences of the clinical trial, and additional informed consent given by a person having the care and custody of the child for patients between 12 and 17 years of age, respectively.
排除标准
- •Patients with non-epileptic seizures or acute symptomatic seizures whose cause can be corrected
- •Patients who suffer from absence seizures or simple partial seizures without motor signs (aura) only
- •Patients who had a chronic focal epilepsy or an epileptic state in their medical history
- •Patients with progressive neurological, degenerative or malignant diseases which are clinically relevant from the investigator's point of view (e.g. cardiovascular or endocrinic diseases)
- •Patients who have been treated with Levetiracetam or Lamotrigine before
- •Patients with known manifest renal insufficiency (creatinine clearance < 80 mL/min)
- •Patients with known hypersensitivity to Levetiracetam, Lamotrigine or another component of the trial drugs
- •Patients who are attended by a legal guardian
- •Patients suffering from a psychiatric disease or affective disorders (within the past 6 months), which had to be treated with electric convulsive therapy, tranquilizing agents, monoamine oxidase inhibitors or CNS-active sympathomimetics (e.g. methylphenidate)
- •Patients who were suffering from alcohol- or drug-addiction within the past 12 months
- •Pregnant or breast-feeding women
- •Patients who participated in another clinical trial within the past 30 days
研究组 & 干预措施
1
Levetiracetam 2000mg/day
干预措施: Levetiracetam (Drug)
2
Lamotrigine
干预措施: Lamotrigine (Drug)
结局指标
主要结局
Rate of seizure-free patients
时间窗: in the first 6 weeks of the trial
次要结局
- Rate of seizure-free patients(during the last 16 weeks)
- rate of seizure-free patients(during the total 26 weeks of the observation period)
- time until the first seizure appears(untin week 26)
- time patients take the study medication(until week 26)
- safety(until end of week 26)
- quality of life during treatment(until week 26)
研究者
Felix Rosenow
Prof. Dr. med; PI
Philipps University Marburg Medical Center