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

Study acronym: TOTEM-RRMS
StatusRecruiting
PhasePhase 2
Started2019-10-29
View on ClinicalTrials.gov ↗

Amendment history

2025-06-27
Study Status, Oversight, IPDSharing v7
Primary completion date2027-01→2027-12
Completion date2027-01→2027-12
2024-09-19
Study Status, Oversight, Eligibility, Contacts/Locations, IPDSharing v6
Eligibility criteria-28 characters
[...] 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) [...]
Study sitescontacts updated at 5 of 5 sites
2024-09-17
Study Status, Eligibility, Contacts/Locations v5
Eligibility criteria+249 characters
[...] one year prior to randomization: natalizumab , fingolimod, ponesimod, ocrelizumab, or ofatumumab, in accordance with their prescri [...] vated by a non-neurological reason (relapse, MRI activity). Patients receiving ocrelizumab within 6 to 9 months are eligible, provided they have received full-dose ocrelizumab for at least 2 years. Biological hypogonadism defined by serum total testosterone [...] 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 inclusio [...] [...]
2023-10-23
Study Status, Sponsor/Collaborators, Oversight, Eligibility, Contacts/Locations, IPDSharing v4
Primary completion date2023-05→2027-01
Completion date2023-05→2027-01
Eligibility criteria+144 characters
[...] of MS, as defined by the revised McDonald criteria, Patient who have been receiving one of the following disease modifying therapies for at least 1one year beforeprior to randomization: natalizumab , fingolimod, ocrelizumab, or ofatumumab, in accordance with their prescribing information. Switching from one ofmolecule theseto treatments:another 1during intravenousthe infusionprevious ofyear natalizumabis also permitted, provided that the switch was motivated by a non-neurological reason (Tysabri®relapse, 300MRI mgactivity) every 4 weeks or fingolimod tablets (Gilenya ® 0.5mg) every day or an i [...] [...]
Study sitescontacts updated at 5 of 5 sites
Collaborators2 to 3 entries
Grünenthal GmbH
2023-03-09
Study Status, Eligibility, Contacts/Locations v3
Study sites4→5
Eligibility criteria+186 characters
[...] of MS, as defined by the revised McDonald criteria, Patient treatedreceiving withfor at least 1 year before randomization one of these treatments: 1 intravenous infusionsinfusion of natalizumab (Tysabri®, 300 mg) once every 4 weeks foror atfingolimod leasttablets 1(Gilenya year® 0.5mg) every day or an infusion of ocrelizumab (Ocrevus ® 600mg) every 6 months. Biological hypogonadism defined by serum testosterone level [...] / L (checked by blood sampling during the inclusion visit) For patients under natalizumab : Negative status for JC virus or JC virus synthesis index ≤ 1 [...]
Show 2 earlier versions
2021-10-18
Study Status, Contacts/Locations v2
Study sitesdetails revised at 3 of 4 sites
2019-11-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-01→2023-05
Completion date2023-01→2023-05
Start dateestimated 2019-06→confirmed 2019-10-29
Study sitesdetails revised at 4 of 4 sites
2019-04-08
Original filing
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).
Trial Details
NCT Number NCT03910738
Lead Sponsor University Hospital, Strasbourg, France
Collaborators: Bayer, Fédération Hospitalo-Universitaire NEUROGENYCS, Grünenthal GmbH
Conditions Multiple Sclerosis, Relapsing-Remitting
Enrollment 40 participants
Start Date 2019-10-29
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-06-29