EUCTR2006-004736-79-CZ进行中（未招募）不适用
A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •Males and females aged 18 - 55 years
- •Diagnosis: Multiple Sclerosis” Relapsing Remitting MS (RRMS)
- •At least 9 T2 lesions or at least 4 if one is gadolinium-enhancing
- •Last relapse in the previous 12 months
- •No relapse in the previous four weeks
- •Score of EDSS 0 – 6.0
- •Reliable contraception (e.g. surgical sterilisation, oral contraceptives)
- •Written informed consent to participate in the study by signature on the Patients Consent Form.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Administration of any investigational drug within the previous 2 months before enrolment (4 months if the previous drug was a new chemical entity)
- •Progressive disease
- •Concomitant clinically relevant other findings on MRI that may interfere with outcome assessment
- •Previous treatment with VLA-4 antibodies, anti-CD4 antibodies, or other monoclonal antibodies
- •Total lymphoid irradiation at any time
- •Treatment with immune-modulating drugs in the previous two months or treatment with immune-suppresive drugs in the previous six months
- •HIV positive patients
- •Detectable levels of JC Virus in the blood measured by Quantitative PCR
- •Patients with renal impairment with serum creatinine ? 2,0 mg/dl
- •History of clinically relevant gastrointestinal, hepatic, renal, endocrine, haematological, metabolic, neurologic (other than MS) and psychiatric disease
- •Patients with infections (lymphocytes > 3000/µL)
- •History of any bleeding
- •History of coagulation abnormalities
- •Concomitant medication acetyl salicylic acid (> 300 mg/day) and phenprocoumon
- •Clinically relevant abnormalities in physical findings at screening examination if interfering with the study objective
- •Pregnant or breast-feeding women
- •History of drug or alcohol abuse
- •Epileptics
- •Suicidal subjects
- •History of drug allergy and/or known drug hypersensitivity
- •Inability to communicate or cooperate with the Investigator due to language problem, poor mental development or impaired cerebral function
- •Any medical condition which, in the judgement of the Investigator, might interfere with the objectives of the study
- •Repeated participation in this study
- •Contraindication for application of study drug
- •Corticoid-treatment in the previous six weeks and during the study period
- •Exceptions:Corticoid-treatment before the study period (not in the previous six weeks) and of relapses during the study period: Relapses are characterised by the occurrence of neurological dysfunction symptoms, appearing after a 30-day period of stability or improvement and lasting for more than 24 hours (no infection, no fever).
- •A 5-day methylprednisolone treatment 1000 mg i.v. is allowed in this case followed by a reducing procedure.
- •Corticoid-treatment if applied locally (e.g. inhaled products) is allowed.
- •Additionally MRI exclusion criteria:
- •-Metal residing in the body (e.g. implants)
- •-Cardiac pacemaker, valves, cochlear implants, CNS vascular clips
- •-Contrast medium allergy (Gd-DTPA)
研究者
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