TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis

Prior treatment

• Patients with hypogonadism with clinical symptoms and treated with androgens
• Patients who used experimental drugs and / or who participated in clinical drug trials in the 6 months prior to selection
• Patient in exclusion period (determined by previous study or in progress)

Other illness

• Patients with any other disease other than MS that may contribute to neurological symptoms and signs or affect their evaluation
• Patients with or having had cancer or tumors of the liver, heart, kidney, prostate or mammary gland
• Patients with cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, uncontrolled diseases
• Patients with chronic infectious disease
• Patients with organic or psychiatric disease compromise their ability to understand the information given and to follow the protocol
• Patients with a history of hypersensitivity to treatment or any of the excipients, or drugs of similar chemical classes

Age

• 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 the inclusion visit)

Other

• Patients with progressive MS (primary or secondary)
• Patients with a hematocrit level \> 54% (checked by blood sampling during the inclusion visit)
• Patients refusing or unable to undergo an MRI
• Patients with neurological signs compatible with progressive multifocal leukoencephalopathy (PML) or confirmed leukoencephalopathy
• Patients diagnosed with untreated sleep apnea
• Patients wishing to procreate during the study period
• Impossibility of giving information to the patient (subject in emergency situation, difficulties in understanding the subject or other)
• Incapacitated subject (subject to a legal protection measure: safeguard of justice, curatorship, guardianship, future protection mandate, family habilitation)

• Man between 18 and 55 years
• Patient affiliated to a social health insurance plan
• Patient able to understand the objectives and risks related to the research and able to comply with the requirements of the protocol throughout the duration of the study
• Patient having been informed of the results of the prior medical examination
• Patient having signed an informed consent
• Confirmed and documented diagnosis of MS, as defined by the revised McDonald criteria,
• Patient who have been receiving one of the following disease modifying 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 (checked by blood sampling at the inclusion visit)
• No relapses in the year prior to inclusion
• Disability status during the selection visit with an EDSS score of 0 to 7 (verified by questionnaire during the inclusion visit)
• Stable neurological state in the month preceding randomization