EUCTR2009-011585-28-FR进行中（未招募）不适用
A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS)
适应症
试验速览
- 阶段
- 不适用
- 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 aged =18 with relapsing-remitting multiple sclerosis (EDSS score 0-5.5), with evidence of disease activity defined as at least one relapse or the presence of active MRI lesion/s consistent with MS during the year prior to inclusion
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •MS-related exclusion criteria:
- •MS relapse or systemic corticosteroids in the previous 1 month
- •Secondary progressive (SPMS), progressive relapsing (PRMS), or primary progressive MS (PPMS)
- •Treatment with other agents for MS within the previous 3 months (intertferon beta, glatiramer acetate, intravenous immunoglobulin or plasmapherese) or within the previous 12 months (other MS drugs)
- •Treatment with agents for the non-symptomatic treatment of MS within the previous 3 months
- •General exclusion criteria
- •Pregnant or breast feeding
- •Participation in a clinical study of an unlicensed drug in the previous 6 months
- •Has a clinically significant abnormal serum biochemistry, haematology or urine examination values within 14 days prior to the start of the study.
- •Has a 12-lead ECG with abnormal QTc interval within 14 days prior to the start of the study.
- •Presence of pacemakers or foreign metal objects in the body which would contraindicate an MRI scan, or renal impairment which would contraindicate gadolinium injection
- •Has any systemic disease, which can influence his/her safety and compliance, or the evaluation of disability.
- •Any finding on medical history or physical examination which would prevent the patient being able to fully comply with the requirements of the study.
- •Any finding on medical history or physical examination which would affect absorption of the study drug; e.g. metabolic disorders.
- •Serious concomitant medical conditions: e.g. HIV infection, Hepatitis B or C, uncontrolled diabetes, malignancy.
- •Current history of cancer, excluding localised non-melanoma skin cancer
- •Known allergies to the study drug, its constituents or gadolinium (MRI contrast).
- •Has suffered from major depression or any other psychiatric disorder
- •Incapability of giving informed legal consent
- •Co-worker, student, relative or spouse of the investigator
- •Patients unable to swallow oral medications
- •Previous participation in this study
研究者
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