TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
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).