LOSIGAMONE AS MONOTHERAPY IN TREATMENT COMPLEX PARTIAL SEIZURES

新药物洛西甘酮单独用于治疗复杂部分性癫痫的安全性和有效性的测定。这是一项随机双盲平行组试验，在随机化前的基线期，患者可以耐受洛西甘酮作为唯一的抗癫痫药物而不增加癫痫发作活动，在此期间，患者将继续使用当前的癫痫发作药物并计数癫痫发作。该试验的目的是为洛西甘酮作为唯一药物的抗惊厥作用提供证据，寻求剂量与耐受性之间的关系，解决对肝脏和肾脏清除的担忧，比较洛西甘酮在男性和女性体内的作用，并提供洛西甘酮对标准抗癫痫药物过程的影响的额外信息。第一阶段将是持续4周的当前癫痫药物治疗和癫痫发作计数。第二阶段的开始是在医院进行夜间访问，以研究单次剂量后losigamone的血液水平。在第二阶段的剩余时间里，将逐渐增加洛西甘酮的剂量，以找到适当的剂量，没有不可接受的副作用，也不会增加癫痫发作。在为期六周的第三阶段，将慢慢停用先前的癫痫药物，并调整洛西甘酮的剂量，以尽量减少副作用，同时不增加癫痫发作。在这一阶段，将实现单药治疗，仅使用losigamone。8周的第4阶段将是唯一使用losigamone和基线癫痫发作计数。最后一天将是入院，届时将收集血液和尿液，以研究身体消除药物的速度。然后受试者将被随机分配到两组中的一组，一组服用相同的最佳剂量，另一组服用最佳剂量的一半。在为期八周的第五阶段，如果癫痫发作次数与基线癫痫发作次数相比，将继续服用未知剂量并持续到该阶段结束。第六阶段将是最后的安全检查和实验室测试，并将确定是否有资格继续进行开放标签扩展研究。

The determination of safety and effectiveness of the new drug losigamone when used alone in the treatment of complex partial seizures. This is a randomized, double-blind parallel group trial using patients who can tolerate losigamone as the onlyantiepilepsy medication without raised seizure activity during the pre-randomization baseline period when, for four weeks, the patient will continue on the current seizure medication and count seizures. The objectives of the trial are to provide evidence of the anticonvulsant effect of losigamone as the only medication, to seek the relationship between the dosage and the tolerability, address concerns about liver and kidey clearance, to compare effects of losigamone in the bodies of males and females, and to provide additional information on the effect of losigamone on the precesses of standard antiepileptic drugs. Phase one will be the four week period of continuation of the current seizure medication and counting of seizures. The beginning of phase two is an overnight visit in the hospital to study blood levels of losigamone after a single dose. During the remainder of phase two, there will be a gradual increase of the dosage of losigamone to find the proper amount with no unacceptable side effects and no increase in seizures. During a six week phase three, the previous seizure medication will be slowly withdrawn and the dosage of losigamone will be adjusted to minimize side effects without increasing seizures. During this phase, monotherapy, using only losigamone, will be achieved. The eight week phase four will be the sole use of losigamone and a baseline seizure count. The last day will be an admission when blood and urine is collected to study how fast the body eliminates the medication. The subject will then be randomly assigned to one of two groups, one taking the same best dose and the other taking one half of the best dose. During the eight week phase five, the unknown doses will be taken and continued to the end of the phase if the number of seizures compares to the number of baseline seizures. Phase six will be final safety examinations and lab tests and eligibility to continue on an open label extension of the study will be determined.