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: 6274910
• 负责人: GREGORY Y CHANG
• 金额: $ 3.67万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274910
• 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 However, during the course of the study concomitant AEDs may be gradually withdrawn so that some patients may be expected to acheive tiagabine HCL monotherapy.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、附加疗法、扩展研究 之前参加过噻加宾盐酸癫痫治疗的患者 学习。然而，在研究过程中，可能会同时使用 AED 逐渐退出，以便一些患者有望达到 盐酸噻加宾单一疗法。这项研究可以在任何地点进行 在美国正在进行或已经进行了噻加宾盐酸盐临床研究 国家。本研究的目的是确定安全性 盐酸噻加宾作为癫痫的慢性疗法。