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RECRUITING
NCT03910738
PHASE2

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

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

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).

Key Details

Gender

MALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2019-10-29

Completion Date

2027-12

Last Updated

2025-06-29

Healthy Volunteers

No

Interventions

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)

Locations (5)

CHU de Besançon

Besançon, France

CHU Nancy

Nancy, France

Hôpital Pitié-Salpêtrière

Paris, France

CHU de Rennes/Pontchaillou

Rennes, France

CHRU de Strasbourg

Strasbourg, France