Kasteleijn-Nolst Trenité D G, Marescaux C, Stodieck S, Edelbroek P M, Oosting J
Instituut voor Epilepsiebestrijding, Heemstede, The Netherlands.
Epilepsy Res. 1996 Nov;25(3):225-30. doi: 10.1016/s0920-1211(96)00031-9.
The experimental antiepileptic drug, levetiracetam (UCB L059), a piracetam analogue has been investigated in photosensitive patients in the "photosensitivity model", an early phase II study. A total of 12 patients (10 females, 2 males) with a mean age of 21.5 years (range 13-38) were investigated during a 3 day period in 3 centres (France, The Netherlands, Germany), using the same standardised method. The subjects were either treated with a single oral dose of 250 mg, 500 mg, 750 mg or 1,000 mg. In addition, 4 patients took 250 mg b.i.d. for 3-5 days, after which they were re-examined. In 9 of 12 photosensitive patients (75%) a clear suppression (3 patients) or abolishment (6 patients) of IPS evoked photoparoxysmal EEG responses was found. This effect appeared to be dose-dependent, the higher the dose the greater the effect; complete abolishment was only seen at dosages of 750 mg and 1,000 mg, occurring at peak plasma levels and lasting between 6 and 30 h. There was no indication of pharmacokinetic interaction with concomitant antiepileptic drugs such as valproic acid, ethosuximide or phenobarbitone. No serious side-effects were seen and some patients reported enhancement of their mood. Two patients with myoclonic jerks noticed a clear reduction of their myoclonus, although this was not one of the objectives of the study. In conclusion, levetiracetam showed a clear antiepileptic effect in the photosensitivity model.
实验性抗癫痫药物左乙拉西坦(UCB L059),一种吡拉西坦类似物,已在“光敏性模型”中对光敏患者进行了研究,这是一项早期II期研究。在3个中心(法国、荷兰、德国),采用相同的标准化方法,在3天内对总共12名患者(10名女性,2名男性)进行了研究,这些患者的平均年龄为21.5岁(范围13 - 38岁)。受试者分别接受250毫克、500毫克、750毫克或1000毫克的单次口服剂量治疗。此外,4名患者每天两次服用250毫克,持续3 - 5天,之后再次接受检查。在12名光敏患者中的9名(75%)中,发现IPS诱发的光阵发性脑电图反应明显受到抑制(3名患者)或消失(6名患者)。这种效果似乎呈剂量依赖性,剂量越高效果越明显;仅在750毫克和1000毫克剂量时观察到完全消失,发生在血浆峰值水平,持续6至30小时。没有迹象表明与丙戊酸、乙琥胺或苯巴比妥等同时使用的抗癫痫药物存在药代动力学相互作用。未观察到严重的副作用,一些患者报告情绪有所改善。两名有肌阵挛抽搐的患者注意到肌阵挛明显减轻,尽管这不是该研究的目标之一。总之,左乙拉西坦在光敏性模型中显示出明显的抗癫痫作用。