Effects of Perampanel on Cognition and Electroencephalography in Patients With Epilepsy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quantitative EEG (qEEG) change
研究概览
简要总结
Perampanel, a novel AED, has been recently authorized in Korea and worldwide as a treatment of refractory partial-onset seizures with a new anti-epileptic mechanism of a selective non-competitive antagonist of AMPA receptors.
Evaluating adverse effects during the introduction of new AED is often difficult since the complaints are subjective and objective assessment is complicated due to the polytherapy. Majority of previous studies are focused on quantitative analysis of EEG for taking new AEDs because of the correlation of EEG analysis results and side effects of AED such as cognitive slowing. Therefore, this study aims to investigate the effects of perampanel on EEG in terms of EEG background spectra and to evaluate perampanel effects by using subjective questionnaires assessing depression, anxiety, sleep quality and fatigue.
详细描述
Perampanel is a selective antagonist of the α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor and is used to treat partial-onset seizures with or without secondary generalization. This antiepileptic drug (AED) is usually prescribed as adjunctive treatment and is also used primarily in generalized tonic-clonic seizures Cognitive dysfunction is a major comorbidity in many patients with epilepsy and could be the result of chronic use of AEDs. Since cognitive decline has a tremendous impact on the quality of life, the effect of a large number of AEDs on cognition has been actively studied. It has been reported that AEDs such as gabapentin, carbamazepine, and topiramate induce cognitive decline, while lamotrigine, levetiracetam, and oxcarbazepine show much less negative effect on cognitive function compared with the older AEDs. Perampanel has also been studied for its effects on cognition in adolescent patients with epilepsy aged 12-18 years. However, the effects of perampanel on cognitive function have not yet been studied in adults.
Electroencephalogram (EEG) spectral analysis or quantitative EEG (QEEG) is a method of quantifying the different frequencies in EEG signals. Spectral analysis of EEG frequency can reflect the functional state of the brain. Thus, it has proved to be a useful tool for assessing the pharmacological effects of central nervous system (CNS) drugs. Electrophysiologic changes due to AEDs can manifest as either a generalized slowing of or an increased beta frequency on EEG in general. Changes in background EEG may be correlated with clinical cognitive function. Since EEG changes in the spectral analysis are only intended to assess brain activity and do not directly reflect clinical changes in patients, neuropsychological (NP) tests are necessary for evaluating clinical cognitive function. Our objective was to determine how perampanel affects cognition and the EEG signal in adult patients with epilepsy. Correlation of these effects was also analyzed with the serum concentration of perampanel.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 18-65 years
- •Provide written informed consent signed by the subject or legal guardian prior to entering the study in accordance with the IRB guidelines
- •Subjects in otherwise good health (with the exception of epilepsy), as determined by the PI via the medical history, a physical examination and screening laboratory investigations including demonstration of normal renal function.
- •Patient with focal-onset seizures with or without secondary generalized seizure
- •History of epilepsy for at least 2 years.
- •The subject must have had an EEG or clinical seizure consistent with partial epilepsy.
排除标准
- •A history of non-epileptic or psychogenic seizures.
- •Women who are pregnant or lactating.
- •Any clinically significant laboratory abnormality which, in the opinion of the investigator, will exclude the subject from the study.
- •Liver transammases (AST and ALT) cannot exceed twice the upper limit of normal and total and direct bilirubin must be within normal limits.
- •An active CNS infection, demyelinating disease, degenerative neurological disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results.
- •Any clinically significant psychiatric illness, psychological or behavioral problems which, in the opinion of the investigator, would interfere with the subject's ability to participate in the study.
- •Suffering from psychotic disorders and/or unstable recurrent affective disorders evident by use of antipsychotics; subject with current major depressive episode (or within 6 months).
- •A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
- •History of regular alcohol consumption exceeding 2-3 units/day for females and 3-4 units/day for males
- •History of regular use of tobacco or nicotine-containing products exceeding the equivalent of 5 cigarettes per day
- •History of regular consumption of caffeine exceeding the equivalent of 4 cups of coffee per day, a level that approximates health-related criteria
- •Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
- •Subjects with more than 1 lifetime suicide attempt or any suicide attempt within the past two years.
研究组 & 干预措施
Epilepsy
Epilepsy patients (focal onset seizure with or without secondary generalization)
干预措施: Perampanel (Drug)
结局指标
主要结局
Quantitative EEG (qEEG) change
时间窗: 6th month
Change of qEEG markers - spectral power: delta, theta, alpha and beta frequency band
次要结局
- Effects on cognition(6th month)
- Effects on seizures(6th month)
- Effects on sleepiness(6th month)
- Effects on depression(6th month)
研究者
Ki-Young Jung
Professor
Seoul National University Hospital