EUCTR2017-004279-30-SE进行中（未招募）1 期
A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E
Santhera Pharmaceuticals (Switzerland) Limited0 个研究点目标入组 266 人开始时间: 2018年5月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 266
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Completion of the SIDEROS study at Visit 8/ Week 78.
- •2. Signed and dated Informed Consent Form.
- •Inclusion criteria for the optional continued treatment with idebenone beyond Visit 4 of SIDEROS-E study:
- •1. Completion of Visit 4/ Week 78 of SIDEROS-E study
- •2. Signed and dated Informed Consent Form for continued treatment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 266
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who discontinued SIDEROS study prematurely (i.e. did not attend all visits from V1 to V8).
- •Safety, tolerability or other issues arising during the course of the SIDEROS study which in the opinion of the Investigator may put the patient at significant risk or may interfere significantly with the patient’s participation in the SIDEROS-E study.
- •Use of any investigational drug other than the study medication.
- •Enrolment in SIDEROS-E of siblings of randomized SIDEROS patients is allowed if they meet all the inclusion and none of the exclusion criteria above.
- •Exclusion criteria for the optional continued treatment with idebenone beyond Visit 4/ Week 78 of SIDEROS-E study:
- •1. Premature withdrawal from SIDEROS-E study before Visit 4/ Week 78
- •2. Any conditions, which, in the opinion of the Investigator might trigger a negative risk-benefit assessment for the patient
- •3. Use of any Investigational drug other than the study medication
研究者
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