EUCTR2015-005347-14-GB进行中（未招募）1 期
Efficacy and safety of low-dose IL-2 (ld-IL-2) as a Treg enhancer for controlling neuro-inflammation in newly diagnosed Amyotrophic Lateral Sclerosis (ALS) patients:A randomized, double-blind, placebo- controlled, phase-II Proof of Concept/ Proof of Mechanism Clinical Trial - MIROCALS
CHU DE NIMES0 个研究点目标入组 216 人开始时间: 2016年5月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 216
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
- •Inclusion criteria for the persons taking part in the trial
- •1 / Run-in period
- •The patient has been correctly informed
- •The patient must have given his/her informed and signed consent.
- •The patient must be 18 years old and less than 76 years old
- •Possible, Probable, Probable laboratory-supported or Definite ALS as defined by El Escorial Revised ALS diagnostic criteria
- •Disease duration = 24 months
- •Slow vital capacity = 70% of normal
- •No prior (ie. less than 4 weeks/ 28 days) or current riluzole treatment; when riluzole treatment is present and the prior duration of treatment is less than or equal to 4 weeks (28 days), a riluzole wash-out period of at least 4 weeks (28 days) must be performed prior to entry.
- •Lumbar punctures accepted by patient and feasible
- •2/ Randomised controlled trial period
- •Run-in period completed, including lumbar puncture and sampling for blood biomarkers at inclusion and at 3 months
- •The patient is willing to continue participation
- •Disease duration = 28 months
- •Stable dose of riluzole treatment for at least 3 months
- •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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 162
排除标准
- •Exclusion criteria for persons taking part in the trial (run-in and Randomised Control Trial periods)
- •The patient is participating in another research study that may interfere with the results or conclusions of this study
- •Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study
- •The patient is in an exclusion period determined by a previous study
- •The patient does not have capacity to give fully informed consent and/or to comply with study requirements and procedures
- •Significant cognitive impairment as judged by investigator on the basis of his/her assessment of the patient, taking into account information from caregivers
- •Other neurodegenerative disease that could explain signs or symptoms
- •Contra indication for lumbar puncture (presence of contra-indicated treatment, –see section 11.3.2, or coagulation test abnormality, clinically significant coagulopathy or thrombocytopenia)
- •Non authorised treatment (see section 11.3 of the protocol)
- •Other disease or disorders that could preclude functional assessments or life-threatening disorders
- •Any Cancer within the past 5 years (except stable non-metastatic basal cell skin carcinoma or in situ carcinoma of the cervix)
- •Severe cardiac or pulmonary disease
- •Any documented, active, past or present ,auto-immune disorders except asymptomatic Hashimoto thyroiditis
- •Using assisted ventilation
- •Gastrostomy
- •Women of child-bearing age and sexually active men without effective contraception or woman who are pregnant or breast feeding
- •Any clinically significant laboratory abnormality (excepting cholesterol, triglyceride and glucose).
- •Clinically significant evidence of active viral infection at randomisation: CMV, EBV, HIV-1, HBV or HCV
- •History of documented symptomatic and treated asthma within the past 5 years
研究者
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