LOSIGAMONE AS MONOTHERAPY IN TREATMENT OF 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: 6264390
• 负责人: KENNETH D LAXER
• 金额: $ 5.16万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264390
• 关键词: anticonvulsants; brain disorder chemotherapy; clinical research; human subject; human therapy evaluation; partial seizure

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.

本试验将评估losigamone治疗复杂部分性癫痫发作患者的安全性和有效性，其中（1）已确定losigamone的最佳剂量，（2）已停用既往抗癫痫药物（AED）（患者除复杂部分性癫痫发作外，还可能出现简单部分性癫痫发作）。 在8周的洛西加蒙单一疗法基线期后，患者将在双盲条件下随机分配至（1）继续其最佳洛西加蒙剂量或（2）滴定至最佳洛西加蒙剂量的一半，并将进入8周治疗期。 将通过可变的从随机化至符合退出标准的时间评估疗效。 将通过比较不良事件的性质和持续时间来评价安全性。该试验将在多个癫痫中心进行。