ADD ON 534U87 IN PARTIAL SEIZURES

癫痫是一种常见的疾病，在美国有250多万人受其影响。需要新的抗惊厥药来治疗50%以上使用现有抗惊厥药仍有部分癫痫发作的患者。这是一种名为534U87的新化合物的前瞻性开放标签II期研究。在患者先前使用抗惊厥药的2个月基线阶段，癫痫发作将被计数，然后在3个月的滴定阶段逐渐添加534U87。在三个月的治疗阶段，癫痫发作将被计算在内。参加研究的前5名患者将在滴定阶段4次或5次剂量增加后每隔2周入院24小时。在24小时GCRC入院期间，每1-2小时采集一次血清样本进行药代动力学研究。

Epilepsy is a common disorder which affects more than 2.5 million people in the United States. New anticonvulsants are needed to treat the more than 50% of patients who continue to have partial seizures on currently available anticonvulsants. This is a prospective, open-label phase II study of a new compound called 534U87. Seizures will be counted during a two month baseline phase on the patient's prior anticonvulsant before 534U87 is gradually added in a three month titration phase. Seizures will then be counted during a three month treatment phase. The first five patients enrolled in the study will be admitted for 24-hours at two week intervals after each of the four or five dosage increases during the titration phase. Serum samples for pharmacokinetic studies will be obtained every 1-2 hours during the 24-hour GCRC admission.