LOSIGAMONE AS MONOTHERAPY IN TREATMENT COMPLEX PARTIAL SEIZURES

洛西加蒙作为治疗复杂性部分性癫痫发作的单一疗法

• 批准号: 6304947
• 负责人: John M Pellock
• 金额: $ 0.06万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6304947
• 关键词: anticonvulsants; brain disorder chemotherapy; clinical research; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; partial seizure

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 During a six week phase three, the previous seizure medication will be slowly withdrawn and the dosage of losigamone will be adjusted to minimize side effects without increasing seizures.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.

新药洛西加酮单药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，患者可以耐受洛西加酮作为唯一的抗癫痫药物，在随机化前基线期内癫痫发作活动不会增加，患者将继续使用当前癫痫发作药物并计数癫痫发作四周。该试验的目的是提供洛西加蒙作为唯一药物的抗惊厥作用的证据，寻求剂量与耐受性之间的关系，解决有关肝脏和肾脏清除率的问题，比较洛西加蒙在男性和女性体内的作用，并提供有关洛西加蒙对标准抗癫痫药物旋进性影响的额外信息。第一阶段将是继续使用当前癫痫发作药物和癫痫发作计数的四周时间。第二阶段的开始是在医院过夜访问，以研究单次给药后losigamone的血液水平。在第二阶段的剩余时间内，将逐渐增加losigamone的剂量，以找到没有不可接受的副作用和癫痫发作增加的适当量。在为期六周的第三阶段，以前的癫痫药物将被缓慢撤回，洛西加蒙的剂量将被调整，以尽量减少副作用，而不会增加癫痫发作。在此阶段，将实现单药治疗，仅使用losigamone。为期八周的第四阶段将是唯一使用洛西加蒙和基线癫痫发作计数。最后一天将是一个入院时，血液和尿液收集，以研究如何快速的身体消除药物。然后将受试者随机分配至两组之一，一组接受相同的最佳剂量，另一组接受最佳剂量的一半。在为期8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，则将服用未知剂量，并持续至阶段结束。第六阶段将是最终的安全性检查和实验室检查，并将确定继续进行开放标签扩展研究的资格。