LOSIGAMONE AS MONOTHERAPY IN TREATMENT OF COMPLEX PARTIAL SEIZURES

这项试验将评估洛格卡蒙治疗复杂部分性发作患者的安全性和有效性，这些患者(1)已确定最佳洛格卡酮剂量，(2)先前的抗癫痫药物(AED)已停用(除复杂部分性发作外，患者还可能出现简单部分性发作)。在为期8周的洛西卡蒙单一治疗基准期之后，患者将在双盲条件下被随机分成两组：(1)继续他们的最佳洛西卡蒙剂量，或(2)滴定到最佳洛西卡蒙剂量的一半，并将进入8周的治疗期。疗效将通过从随机化到达到退出标准的可变时间进行评估。安全性将通过比较不良经历的性质和持续时间进行评估。这项试验将在多个癫痫中心进行。

This trial will evaluate the safety and efficacy of losigamone in the treatment of patients with complex partial seizures in whom (1) an optimal losigamone dosage has been determined and (2) the previous antiepileptic drug (AED) has been discontinued (patients may present with simple partial seizures in addition to complex partial seizures). After an 8-week losigamone monotherapy baseline period, patients will be randomized under double-blind conditions to either (1) continue their optimal losigamone dosage or (2) titrate to one-half the optimal losigamone dosage and will enter an 8-week treatment period. Efficacy will be assessed by the variable time-from-randomization-to-meeting-exit criteria. Safety will be evaluated by comparing the nature and duration of the adverse experiences. The trial will be conducted at multiple epilepsy centers.