EUCTR2011-005249-12-ES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 - TERIKIDS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 165
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
入选标准
- •- Patients with relapsing multiple sclerosis (MS) based on McDonald criteria of 2010 and International Pediatric Multiple Sclerosis Study Group (IPMSG) criteria for pediatric MS:
- •-at least one relapse in the 12 months preceding randomization, or
- •-at least 2 relapses in the 24 months preceding randomization.
- •- Equal or less than 17 years of age and equal or greater than 10 years of age at randomization.
- •- Signed informed consent/assent obtained from patient and patient's legal representative.
- •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
- •- Expanded disability status scale (EDSS) score greater than 5.5 at screening or randomization visit.
- •- Relapse within 30 days prior to randomization.
- •- Treated with cladribine or mitoxantrone within 2 years preceding randomization.
- •- Treated with glatiramer acetate, interferons, natalizumab, introvenous immunoglobulins or other immunosuppressant or immunomodulatory agents such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, dimetthyl fumrate, fingolimod less than 3 months or five half-lives prior to randomization, whichever is greater.
- •- History of human immunodeficiency virus (HIV) infection.
- •- Contraindication for magnetic resonance imaging (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 contraceptives or (double barrier) contraceptive method.
研究者
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