2024-517845-14-00招募中2 期
TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis (TOTEM-RRMS)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- 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.
研究概览
简要总结
To evaluate the remyelinating and neuroprotective effect of testosterone treatment used for 54 weeks in patients with RRMS treated with natalizumab , fingolimod, ponesimod, ocrelizumab or ofatumumab on a criterion combining the analysis of thalamus atrophy and diffusion tensor measured by MRI.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Man between 18 and 55 years
- •Confirmed and documented diagnosis of MS, as defined by the revised McDonald criteria
- •Patients who have been receiving one of the following diseasemodifying therapies for at least one year prior to randomization: natalizumab , fingolimod, ponesimod, ocrelizumab, or ofatumumab, in accordance with their prescribing information. . Switching from one molecule to another during the previous year is also permitted, provided that the switch was motivated by a non-neurological reason (relapse, MRI activity).Patients receiving ocrelizumab within 6 to 9 months are eligible, provided they have received full-dose ocrelizumab for at least 2 years".
- •Biological hypogonadism defined by serum total testosterone levels below 20 nmol / L (checked by blood sampling during the screening visit)
- •For patients under natalizumab :Negative status for JC virus or JC virus synthesis index ≤ 1.5 (within 6 months prior to screening visit)
- •No relapses in the year prior to inclusion
- •Stable neurological state in the month preceding randomization
排除标准
- •Patients with progressive MS (primary or secondary)
- •Patients with chronic infectious disease
- •Patients with a history of hypersensitivity to Nebido® or any of the excipients, or drugs of similar chemical classes
- •Patients who used experimental drugs and / or who participated in clinical drug trials in the 6 months prior to selection
- •Patients with hypogonadism with clinical symptoms and treated with androgens
- •Patients with PSA (prostate specific antigen)> 2.5 ng / ml (for an age less than 49 years old) or> 3.5 ng / ml (for age ≥ 50 years) (checked by a blood test at screening visit)
- •Patients with a hematocrit level > 54% (checked by blood sampling during the screening visit)
- •Patients with any other disease other than MS that may contribute to neurological symptoms and signs or affect their evaluation
- •Patients with neurological signs compatible with PML or confirmed PML
- •Patients diagnosed with untreated sleep apnea
- •Patients with or having had cancer or tumors of the liver, heart, kidney, XML File Identifier: 0bHUQtIJ9JZx4QdRJTxm0++LBOc= Page 12/24 prostate or mammary gland
- •Patients with cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, uncontrolled diseases
结局指标
主要结局
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.
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.
次要结局
- 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®).
研究者
Nicolas COLLONGUES
Scientific
Les Hopitaux Universitaires De Strasbourg
研究点 (5)
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