ADD ON 534U87 IN PARTIAL SEIZURES

这项研究是一项国际化、多中心、试点、开放式的评估 534U87附加治疗的安全性、耐受性和有效性 部分癫痫发作。 534U87的安全性和耐受性将通过不良事件进行评估 报告、临床实验室评估、生理和神经学 检查、心电图、生命体征、身高和体重。 可能与其他伴随的AEDs的药物相互作用也将是 在这场审判中进行了评估。 这项研究的有效性的初步证据将基于 癫痫发作频率的测量，包括受试者的比例 癫痫发作频率减少50%。就本研究而言， 部分性癫痫的定义为：目的(行为或运动 患者和/或其家人/照顾者明显的症状/ 伴生)简单部分(类型A)、复杂部分(类型B)，以及 继发性全身性强直-阵挛、阵挛或强直(C型)发作。 这项研究将招收足够的受试者来产生100名“完成者”。 受试者，即通过维护完成研究的受试者 阶段(预计招生&lt；150门)。

This study is an international, multicenter, pilot, open-label evaluation of the safety, tolerability, and efficacy of 534U87 add-on treatment of partial seizures. The safety and tolerability of 534U87 will be assessed by adverse event reporting, clinical laboratory assessments, physical and neurological examinations, electrocardiograms, vital signs, and body height and weight. Possible drug interactions with other concomitant AEDs will also be assessed during this trial. Preliminary evidence of efficacy for this study will be based on measurements of seizure frequency, including the proportion of subjects with 50% reduction in seizure frequency. For the purposes of this study, partial seizures are defined as: objective (behavioral or motor manifestations obvious to the patient and/or his/her family/caregiver/ companion) simple partial (Type A), complex partial (Type B), and secondarily generalized tonic-clonic, clonic or tonic (Type C) seizures. The study will enroll sufficient subjects to yield 100 "completer" subjects, i.e. subjects who complete the study through the Maintenance Phase (expected enrollment <150 subjects).