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).
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
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 hematocrit level > 54% (checked by blood sampling during the inclusion visit)
University Hospital, Strasbourg, France
Lead sponsor
Bayer
Collaborator
Fédération Hospitalo-Universitaire NEUROGENYCS
Collaborator
Grünenthal GmbH
Collaborator