TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis (TOTEM-RRMS)
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- STATUS
- Recruiting
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- End date
- May 25, 2023
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- participants needed
- 40
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- sponsor
- University Hospital, Strasbourg, France
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).
Details
| 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 Identifier | NCT03910738 |
| Sponsor | University Hospital, Strasbourg, France |
| Last Modified on | 17 February 2022 |
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