ISRCTN94839639已完成4 期
A multicentre, double-blind, randomised, phase IV clinical trial comparing the safety, tolerability and efficacy of levetiracetam versus lamotrigine and carbamazepine in the oral antiepileptic therapy of newly diagnosed elderly patients with focal epilepsy
niversity of Mainz Medical Faculty (Germany)0 个研究点目标入组 360 人开始时间: 2006年9月12日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
研究概览
简要总结
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25684224 (added 11/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 60 years or above
- •2. New onset focal epilepsy (either at least one epileptic seizure in the last six months and focal epileptiform discharges on electroencephalogram (EEG) or a relevant lesion on computed tomography (CT)/magnetic resonance imaging (MRI) or at least two epileptic seizures, one of which occurred in the last six months prior inclusion)
- •3. No previous anti-epileptic drug (AED) treatment, except for a period not longer than four weeks prior to inclusion (V0)
- •4. Ability of subject to understand verbal and written instructions, to comply with all study requirements, and to comprehend character and individual consequences of the clinical trial
- •5. Written informed consent before enrolment in the trial
排除标准
- •Subjects presenting with any of the following criteria will not be included in the trial:
- •1. Acute symptomatic epileptic seizures occurring acutely within a two week period after the onset of an acute illness such as cerebral haemorrhage, cerebral infarct, rapid progressive malignancy or other acute brain abnormalities (i.e. encephalitis, hypoxic brain damage, trauma, metabolic derangement, following brain surgery)
- •2. Dementia (as defined by history)
- •3. Renal insufficiency as defined by glomerular filtration rate (GFR) less than 50 ml/min
- •4. Increased liver enzymes (glutamic-oxaloacetic transaminase [GOT], glutamic-pyruvic transaminase [GPT], gamma-glutamyl-transferase [gGT]) or increased bilirubin more than or equal to twofold the upper limit of normal (ULN)
- •5. Pre-treatment with valproic acid within the four weeks prior inclusion (V0)
- •6. Contraindication against or history of hypersensitivity to any of the investigational medicinal products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal products
- •7. Participation in other clinical trials
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