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

  • End date
    May 25, 2023
  • participants needed
  • sponsor
    University Hospital, Strasbourg, France
Updated on 17 February 2022
relapsing multiple sclerosis


Centra nervous system (CNF) damage in multiple sclerosis (MS), are mainly attributed to myelin destruction, axonal abnormalities and subsequent degeneration, and are responsible for serious deficiencies. Current therapies are focused on the treatment of inflammation with several types of anti-inflammatory agents. However, there is an urgent need for innovative therapies promoting neuroregeneration and particularly myelin repair.

It has been demonstrated that testosterone can act through neural androgen receptors to promote proliferation and differentiation of oligodendrocyte precursors into mature oligodendrocytes in a cuprizone-induced animal model of demyelination. The rare clinical trials on testosterone are mainly exploratory. Here, we sought to demonstrate an effect of testosterone supplementation in testosterone-deficient patients in a multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 2 trial.

The main objective will be to determine the neuroprotective and remyelinating effects of testosterone using tensor diffusion imaging techniques and thalamic atrophy analyzes.

As secondary objectives, we would like to study the impact of testosterone supplementation on other conventional and unconventional MRI parameters and on clinical outcomes (cognition, fatigue, quality of life, impact on work / activity and anxiety / depression).

Condition Multiple Sclerosis, Relapsing-Remitting
Treatment MRI, Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection, Placebo 4 mL Solution for Injection, Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities, Assessment of disability
Clinical Study IdentifierNCT03910738
SponsorUniversity Hospital, Strasbourg, France
Last Modified on17 February 2022


Yes No Not Sure

Inclusion Criteria

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 treated with intravenous infusions of natalizumab (Tysabri, 300 mg) once every 4 weeks for at least 1 year
Biological hypogonadism defined by serum testosterone levels below 15 nmol / L (checked by blood sampling during the inclusion visit)
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

Exclusion Criteria

Patients with progressive MS (primary or secondary)
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 the inclusion visit)
Patients with a hemoglobin concentration> 16 g / dL (checked by blood sampling during the inclusion visit)
Patients refusing or unable to undergo an MRI
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 progressive multifocal leukoencephalopathy (PML) or confirmed leukoencephalopathy
Patients diagnosed with untreated sleep apnea
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 wishing to procreate during the study period
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
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)
Impossibility of giving information to the patient (subject in emergency situation, difficulties in understanding the subject or other)
Patients under tutors or curators
Patients under the protection of justice
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