NCT01318421终止1 期
An Open-Label, Long-Term, Follow-Up Study of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 主要终点
- To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT).
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and tolerability of ELND002 in patients with multiple sclerosis (MS) after participation in study MS103.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study is open only to subjects who have completed the week 12 visit in study ELND002-MS103 while taking their assigned dose of study drug.
排除标准
- •Subject has no new medical contraindications to continue participation in the study.
研究组 & 干预措施
ELND002
Experimental
ELND002 sc injection
干预措施: ELND002 (Drug)
结局指标
主要结局
To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT).
时间窗: 1 year
Safety and tolerability will be assessed by frequency and severity of AEs.
次要结局
- To evaluate the PK/PD/BM measurement of ELND002 in patients with MS.(1 year)
研究者
相似试验
终止
3 期
An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular DystrophyDuchenne Muscular DystrophyNCT03532542Sarepta Therapeutics, Inc.171
已完成
2 期
ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's DiseaseAlzheimer's DiseaseNCT00934050OPKO Health, Inc.103
已完成
3 期
Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult SubjectsPsoriasisNCT00111436Amgen912
终止
2 期
[S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.PainNCT00354094Pfizer600
已完成
3 期
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)Short Bowel SyndromeNCT00930644Shire88