STUDY OF THE SAFETY OF LONG TERM TIAGABINE HCL ADMINISTRATION

长期服用盐酸替加宾的安全性研究

• 批准号: 6113676
• 负责人: GREGORY Y CHANG
• 金额: $ 3.97万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6113676
• 关键词: anticonvulsants; brain disorder chemotherapy; clinical research; clinical trials; combination chemotherapy; drug administration rate /duration; drug screening /evaluation; epilepsy; human subject; human therapy evaluation; pharmacokinetics

This is an open-label, noncomparative, add-on therapy, extension study in patients 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 However, during the course of the study concomitant AEDs may be gradually withdrawn so that some patients may be expected to acheive tiagabine HCL monotherapy. This study may be conducted at any site that is conducting or has conducted, tiagabine 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.

这是一项开放标签、非比较、添加治疗、扩展研究， 既往参加过盐酸噻加滨癫痫治疗的患者 study.然而，在研究过程中，可能会伴随使用AED。 逐渐撤回，以便一些患者可能会达到预期效果。 盐酸噻加滨单药治疗。本研究可在符合以下条件的任何研究中心进行 正在或已经在美国进行盐酸噻加滨临床研究 States.本研究的目的是确定 盐酸噻加宾作为癫痫的长期治疗。