Single-centre, Observational Study, Concerning Blood-lipid Biomarkers of the Response to Treatment With Biotine, Prescribed in the Context of a Nominative TAU (Temporary Authorized Use) in Patients With an Inactive Progressive Form of Multiple Sclerosis (MS).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- validated disability scale (EDSS)
研究概览
简要总结
Biotine is proposed by neurologists to patients with a progressive form of Multiple sclerosis (MS) in the context of a nominative temporary authorization for use (TAU) as a disease-modifying treatment for their MS. A recent study showed that with this treatment, more patients experienced an improvement after one year in comparison with patients given a placebo.
The objective of this study is to identify blood biomarkers to determine good responders as early as possible. In addition, the blood parameters studied will make it possible to better understand the mechanisms of action, that have a beneficial effect on multiple sclerosis.
The management of patients will not be modified: same number of consultations (at the prescription, at 3 months, at 12 months), same clinical examination, and the same number of blood samples (at the prescription, at 3 months, and at 12 months).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years old
- •inactive progressive form of MS according to the Lublin classification and recorded in the Burgundy EDMUS database
- •Patients with health insurance cover
- •Patients who have provided written informed consent (OFSEP)
排除标准
- •Patients unable to understand the information sheet
- •Patients with remittent or active progressive MS
- •Patients with a change in the disease-modifying treatment within the previous 3 months
- •Patients treated with corticosteroids in the month before inclusion
- •Impossibility to provide patients with the necessary information
- •Patients in custody
- •Patients under guardianship
结局指标
主要结局
validated disability scale (EDSS)
时间窗: change from baseline validated disability scale at 3 and 12 months
Walking test
时间窗: change from baseline walking test at 3 and 12 months
Evolution of blood lipid biomarkers
时间窗: change from baseline evolution of biomarkers at 3 and 12 months
次要结局
未报告次要终点