ACTRN12608000226303已完成2 期
A double-blind, placebo controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Males and females aged 18 to 55 years
- •Diagnosis of Relapsing Remitting Multiple Sclerosis (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 to 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
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-suppressive 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 greater than or equal to 2,0 mg/dl.
- •History of clinically relevant gastrointestinal, hepatic, renal, endocrine, haematological, metabolic, neurologic (other than multiple sclerosis (MS)) and psychiatric disease.
- •Patients with infections (lymphocytes greater than 3000/microL).
- •History of any bleeding.
- •History of coagulation abnormalities.
- •Concomitant medication acetyl salicylic acid (greater than 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 are 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 intravenous (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 Gadolinium Diethylenetriamine Penta-Acetic Acid (Gd-DTPA).
- •No MRI exclusion criteria but caution is advised in case of: Cardiovascular disease including coronary heart disease, Immune deficiency, Haematologic disorder.
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