PLACEBO CONTROLLED STUDY TO EVALUATE GANAXOLONE IN COMPLEX PARTIAL SEIZURES

评估加奈索酮治疗复杂部分性癫痫发作的安慰剂对照研究

• 批准号: 6276465
• 负责人: KENNETH D LAXER
• 金额: $ 6.43万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 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 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6276465
• 关键词: adult human (21+); anticonvulsants; brain disorder chemotherapy; clinical research; drug screening /evaluation; electroencephalography; hospital patient care; human subject; human therapy evaluation; partial seizure; placebos; telemetry; video recording system

GNX 104 is a Phase II in-patient placebo-controlled monotherapy trial of the experimental anticonvulsant ganaxolone in adults with refractory partial epilepsy whose regular anti-convulsants have been discontinued during a routine hospital admission on 8 Long immediately preceding this study for EEG/video telemetry to determine their suitability for surgical treatment of seizures. The study will evaluate the safety, tolerability and efficacy of ganaxolone.

GNX 104是一项II期住院安慰剂对照单一疗法试验 成人难治性癫痫的实验性抗惊厥药物加纳索龙 常规抗惊厥药物已停用的部分性癫痫 在紧接之前的8号的例行入院期间 脑电/视频遥测技术在外科手术中的适用性研究 癫痫的治疗。这项研究将评估安全性、耐受性 和甘纳松龙的疗效。