An Open-Label, Multi-Center Study to Evaluate the Safety, Efficacy and Tolerability of Eteplirsen in Early Stage Duchenne Muscular Dystrophy

Sarepta Therapeutics, Inc.0 个研究点目标入组 40 人开始时间: 2017年3月28日最近更新: 2017年4月3日

试验速览

暂无简介。

•1. Male 4-6 years of age
•2. Diagnosis of DMD, genotypically confirmed
•3. Stable dose of oral corticosteroids for at least 12 weeks or has not received corticosteroids for at least 12 weeks
•4. Intact right and left biceps muscles or two alternative upper arm muscle groups
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Use of any pharmacologic treatment (other than corticosteroids) within 12 weeks that may have an effect on muscle strength or function (e.g., growth hormone, anabolic steroids)
•2. Previous or current treatment with any other experimental treatments within 12 weeks or participation in any other clinical trial within 6 months
•3. Major surgery within 3 months prior to the first dose of study drug, or planned surgery during this study which would interfere with the ability to perform study activities
•4. Presence of other clinically significant illness

发起方