NCT00819897终止不适用
Longitudinal Study in Clinical Isolated Syndrome Patients Treated With Interferon Beta. Correlation With Cognitive Disorders and Quality of Life.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 17
- 主要终点
- Clinical exams performed at Baseline and every year during 3 years Neurological examination: relapses recording and EDSS. Quality of life: SEP-59, MusiQOL. Neuropsychological screening
研究概览
简要总结
The aim of this study is to evaluate the role of cognitive disorders and quality of life in patients with CIS, considered as high risk to develop an MS, treated with interferon Beta. This prospective observational study will include 120 patients, all treated and evaluated annually with neurological extensive examination, ophthalmologic screening (OCT, OF, VEP, VF), auto questionnaire about fatigue (musicol, ELIF), quality of life (SEP-59), and conventional MRI.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years,
- •Patients with CIS and temporo spatial dissemination for less than one year
- •Patient without prior immunomodulatory treatment
- •Patient informed of CIS diagnosis and MS according to McDonald criteria,
- •Patients with EDSS inferior or egal to 5,5
- •Patients usually french-reader and with MMS >24
- •Patients informed of study protocol
- •Patients agree to sign informed consent
- •Patients with affiliation number from social French département.
排除标准
- •Secondary progressive MS
- •Patient with acute relapse
- •Patient already treated with IFN
- •corticosteroids less than 15 days
- •Patient with severe dépressive disorders
- •Patient already included in clinical study
- •Patient < 18 years
- •Patient with known contra indications for beta interféron
- •Every reason with can provoke an interruption of the study, regarding a patient empechment
- •Contre indications for MRI or other tests required in the study
- •pregnancy or lactation
- •patient Under juridic protection
结局指标
主要结局
Clinical exams performed at Baseline and every year during 3 years Neurological examination: relapses recording and EDSS. Quality of life: SEP-59, MusiQOL. Neuropsychological screening
时间窗: 3 years
次要结局
- Fatigue test: MS Fatigue, MRI (T1 gadolinium, T2, sagittale T1, acquisition volumique 3D T1), Optical coherence tomography (OCT)(3 years)
研究者
研究点 (17)
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