SAFETY AND EFFICACY OF TIAGABINE HCL AS ADJUNCTIVE TREATMENT

替加宾盐酸盐作为辅助治疗的安全性和有效性

• 批准号: 6113635
• 负责人: GREGORY Y CHANG
• 金额: $ 3.56万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 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/6113635
• 关键词: anticonvulsants; carbamazepine; clinical research; combination chemotherapy; drug screening /evaluation; human subject; human therapy evaluation; nervous system disorder chemotherapy; neurotransmitter transport; partial seizure; phenytoin; transport inhibitor

This is an open-lavel, noncomparative, add-on therapy, extension study in patient who have previously participated in a tiagabine HCL epilepsy study. However, during the course of the study concomitant AEDs may be gradually withdrawn so that some patients may be expected to achieve tiagabine HCL monotherapy. This study may be conducted at any site that is conducting or has conducted, tiagabin HCL clinical studies in the United States. The objective of this study is to determine the safety of tiagabine HCl as chronic therapy for epilepsy.

这是一项在既往参加过盐酸噻加滨癫痫研究的患者中进行的开放性、非比较性、添加治疗、扩展研究。然而，在研究过程中，可能会逐渐停用伴随使用的AED，因此预计部分患者可能会实现盐酸噻加滨单药治疗。 本研究可在美国正在或已经进行盐酸噻加宾临床研究的任何研究中心进行。 本研究的目的是确定盐酸噻加宾作为癫痫长期治疗的安全性。