EUCTR2011-005249-12-SI进行中（未招募）1 期
A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
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
- All
入选标准
- •-Patients with relapsing multiple sclerosis are eligible. Patients should meet the criteria of MS based on McDonald criteria 2010 and International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, version of 2012 (5) and have:
- •- at least one relapse (or attack) in the 12 months preceding randomization or
- •- at least two relapses (or attack) in the 24 months preceding randomization
- •-=17 years of age and =10 years of age at randomization
- •-Signed informed consent/assent obtained from patient and patient’s legal representative (parents or guardians) according to local regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 165
- •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
排除标准
- •EDSS score > 5.5 at screening or randomization visits
- •Relapse within 30 days prior to randomization
- •Treated with
- •- glatiramer acetate, interferons, or dimethyl fumarate within 1 month prior to randomization
- •- fingolimod, or intravenous immunoglobulins within 3 months prior to randomization
- •- natalizumab, other immunosuppressant or immunomodulatory agents such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, within 6 months prior to randomization
- •- cladribine or mitoxantrone within 2 years prior to randomization
- •Treated with alemtuzumab at any time
- •History of HIV infection
- •Contraindication for MRI
- •Pregnant or breast-feeding females or those who plan to become pregnant during the study
- •Female patients of child-bearing potential not using highly effective contraceptive method (contraception in both female and male is required).
研究者
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3 期
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