SAFETY OF TIZANIDINE IN PATIENTS WITH MS--OPEN LABEL EVALUATION

替扎尼定对多发性硬化症患者的安全性——开放标签评估

• 批准号: 6281660
• 负责人: Jerry Saul Wolinsky
• 金额: $ 1.36万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 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/6281660
• 关键词: alpha adrenergic agent; anticholinergic agent; clinical research; clinical trials; dosage; drug screening /evaluation; human subject; human therapy evaluation; longitudinal human study; multiple sclerosis; muscle relaxants; nervous system disorder chemotherapy; oral administration; placebos

This multicenter, open-label long-term study is a followup to the placebo- controlled study to determine a) the safety and b) the efficacy of oral tizanidine in reducing excessive muscle tone associated with spasticity in patients with multiple sclerosis. This study will determine the safety of long-term treatment with tizanidine at maximally tolerated dosage of up to 12 mg three times a day. This study was completed with FDA approval of tizanidine with an indication for use for treatment of spasticity associated with multiple sclerosis.

这项多中心、开放标签的长期研究是对安慰剂的随访， 对照研究，以确定a）口服给药的安全性和B）疗效 替扎尼定可降低与痉挛相关的过度肌张力， 多发性硬化症患者 本研究将确定 替扎尼定长期治疗，最大耐受剂量为 12毫克，一天三次。 本研究是在FDA批准替扎尼定后完成的， 用于治疗与多发性硬化相关痉挛适应症 硬化症