EUCTR2008-005008-24-GB进行中（未招募）1 期
Worms for immune regulation of multiple sclerosis - MS and hookworm
niversity of Nottingham0 个研究点目标入组 71 人开始时间: 2011年5月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 71
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
- •Inclusion criteria
- •1)Relapsing remitting MS (RRMS) (McDonald criteria), MRI scan consistent with MS by Barkhof or Fazekas criteria
- •2)Patients with at least 1 relapse in the last 12 months or 2 in the last 24 months;
- •3)Patients with Expanded disability status scale (EDSS) score in the range of 0 to 5.5 at the screening and w0 visit
- •4)Patients of both genders, age >18 years and < 60 years
- •5)Women of child bearing potential, (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study.
- •6)Be able and willing to comply with study visits and procedures per protocol.
- •7)Understand and sign consent form at the screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Exclusion criteria
- •No populations at risk of severe illness or death will be included in this study
- •Life expectancy < 6 months.
- •Patient is < 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ.
- •Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
- •Patients with severe and/or uncontrolled medical condition.
- •Pregnancy, lactation or intention to become pregnant during the course of the study (please also see above under inclusion criterion 5)
- •Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
- •Anaemia (Hb <10 g/dL for females, <11 g/dL for males)
- •Prior or present evidence of parasitic infection; prior treatment with anti-helminthic drugs
- •Patient with serious medical or psychiatric illness that could potentially interfere with the completion of the study treatment according to this protocol
- •History of poor compliance or history of drug/alcohol abuse, or excessive alcohol consumption that would interfere with the ability to comply with the study protocol,
- •Severe asthma, allergy, other autoimmune disease or any condition that the physician judges could be detrimental to subjects participating in this study; including deviations deemed clinically important from normal clinical laboratory
- •Previous treatment
- •Treatment with interferon or glatiramer acetate or immunosuppressive drugs within 8 weeks prior to baseline
- •Treatment with bone marrow transplantation, total lymphoid irradiation, monoclonal antibodies, umbilical cord stem cells, AIMSPRO at any time prior to baseline
- •Treatment with corticosteroids or ACTH within 4 weeks prior to baseline
- •Treatment with any investigational agent within 12 weeks prior to baseline
研究者
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