TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis (TOTEM-RRMS)

Relapsing Remitting Multiple sclerosis

Binary criterion comparing the success rate in each treatment group, defined by thalamic atrophy less than 0.5% per year and / or a decrease in transverse diffusivity in lesions less than 0.5% per year.

Efficiency of treatment by imaging: XML File Identifier: 0bHUQtIJ9JZx4QdRJTxm0++LBOc= Page 13/24 • evolution of conventional MRI parameters: volume and number of T1 hypointense lesions, volume and number of new or enlarged T2 lesions, total volume of hyper-intensity FLAIR. • evolution of unconventional MRI parameters: diffusion tensor imaging (NODDI), quantitative magnetization transfer imaging (MPF)., Clinical efficiency of treatment: • Brief International Cognitive Assessment for Multiple Sclerosis, test consisting of the symbol digit modalities test, the California Verbal Learning Test Second Edition, and the Brief Visuospatial Memory Test Revised test • Changes in quality of life and health-related quality of life as measured by the SF-36 and EQ-5D questionnaires respectively., Clinical efficiency of treatment:Impact of MS on workplace productivity and day-to-day activities, as assessed by the WPAI (Work productivity and activity impairment) questionnaire. • Impact on fatigue, as measured by the Multi-Dimensional Fatigue Impact Scale (MFIS),, Clinical efficiency of treatment:Hospital assessment scale for anxiety and depression, as measured by the hospital anxiety and depression scale (HADS) questionnaire. • Evolution of handicap by the EDSS Score, Safe use of the treatment: number and nature of adverse events, evaluation of vital signs at each visit, clinical and neurological examinations, biological results, locally interpreted MRI for tolerance (non-MS pathology of the CNS) and monitoring of concomitant medications ( outside Tysabri®).

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