NCT01071512已完成不适用
Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Cognitive Function Over Time
研究概览
简要总结
The long-term objective is to further establish the role of Tysabri in preventing neurological degeneration in multiple sclerosis (MS) and to establish powerful and efficient new markers for neurological degeneration in MS. The study intends to correlate cognition with two instruments and their measurements-MRI and OCT (optical coherence tomography).
详细描述
The specific aims are:
- To determine the effects of Tysabri on cognition (memory, thought processes, etc.)
- To determine the effects of Tysabri on specific MRI markers for cognitive dysfunction
- To determine the effects of Tysabri on retinal nerve fiber layer thickness (RNFL) using optical coherence tomography (OCT), a special instrument used in ophthalmology
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 through 60 years of age inclusive
- •Diagnosis of relapsing remitting multiple sclerosis
- •Prior to treatment phase, have had disease activity with at least 1 documented relapse during the previous year OR 2 documented relapses during the previous 2 years OR one or more new MRI lesions (Gd+ and/or T2 hyperintense)
- •An Expanded Disability Status Scale (EDSS) score of 0-4.5 inclusive
- •Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to treatment
- •Never been treated with Tysabri/natalizumab.
排除标准
- •Another type of MS other than relapsing remitting multiple sclerosis (RRMS)
- •A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome/immunocompromised
- •A history or presence of cancer (except for successfully treated basal or squamous cell carcinoma of skin)
- •Active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively
- •Have received any live or live attenuated vaccines (including for varicella-zoster virus or Measles) within the last 2 months
- •Have received total lymphoid irradiation or bone marrow transplantation
- •Have been treated with: corticosteroids or adrenocorticotropic hormones (ACTH) within the last month, IFN-β or glatiramer acetate within the last 3 months, immunosuppressive medications such as azathioprine or methotrexate within the last 6 months, immunoglobulins and/or monoclonal antibodies (including natalizumab) within the last 6 months, or cladribine, cyclophosphamide or mitoxantrone at any time.
- •Any medically unstable condition or a progressive neurological disorder, other than MS, which may affect participation in the study
- •History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease
- •Unable to undergo MRI scans, including claustrophobia, have a pacemaker or history of hypersensitivity to gadolinium-DTPA
- •Have had a relapse within 30 days prior AND/OR not stabilized from a previous relapse
- •History of severe allergic or anaphylactic reactions or known drug hypersensitivity to natalizumab/Tysabri
- •A clinically significant infectious disease, such as cellulitis, pneumonia, septicemia
- •History of progressive multifocal leukoencephalopathy(PML)
- •Participation in any clinical research study evaluating another investigational drug or therapy within the last 6 months
- •History of Tysabri therapy
- •Abnormal screening blood test
- •Females who are not postmenopausal for at least 1 year, surgically sterile or willing to practice effective contraception during the study
- •Nursing mothers, pregnant women, and women planning to become pregnant while on study
研究组 & 干预措施
Tysabri
Experimental
Natalizumab 300 mg IV every 4 weeks
干预措施: Tysabri (Drug)
结局指标
主要结局
Change in Cognitive Function Over Time
时间窗: Baseline, 48 weeks, 96 weeks
Cognitive function was assessed using the oral version of the Symbol Digit Modalities Test (SDMT). The number of correct responses in 90 seconds was recorded (possible range 0-110). For analysis, SDMT scores were converted to z-scores using published age and education based norms. A negative z-score indicates a SDMT score below the mean based on the age and education based norms, for example a z-score of -2 = 2 standard deviations below the mean; a positive z-score indicating a score above the mean. Higher scores indicate better cognitive function.
次要结局
- Change Over Time in Retinal Nerve Fiber Layer Thickness(Baseline, 24, 48, 72, and 96 weeks)
- Change Over Time in Normalized Thalamic Volume(Baseline, 48 weeks, 96 weeks)
- Change Over Time in Normalized Hippocampal Volume(Baseline, 48 weeks, 96 weeks)
- Change Over Time in Brain Parenchymal Fraction(Baseline, 48 weeks, 96 weeks)
研究者
研究点 (1)
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