NCT03910738

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection	Active treatment (Nebido® Testosterone Undecanoate ) will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)
DRUG	Placebo 4 mL Solution for Injection	Placebo will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)
PROCEDURE	MRI	Conventional MS sequences (OFSEP recommendations) and unconventional MRI sequences (Baseline, week 30 and 66)
BEHAVIORAL	Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities	BICAMS; SF-36 and EQ-5D-3L; MFIS; HADS; WPAI:MS (at baseline, week 30 and 66)
BEHAVIORAL	Assessment of disability	EDSS (Baseline, week 30 and 66)

Timeline

• Start date: 2019-10-29
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2019-04-10
• Last updated: 2025-06-29

Locations

5 sites across 1 country: France