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TestOsterone TreatmEnt on neuroprotection and Myelin repair in Relapsing Remitting Multiple Sclerosis (TOTEM-RRMS)
EU CTIS ID: 2024-517845-14-00
What this study is testing
To evaluate the remyelinating and neuroprotective effect of testosterone treatment used for 54 weeks in patients with RRMS treated with natalizumab , fingolimod, ponesimod, ocrelizumab or ofatumumab on a criterion combining the analysis of thalamus atrophy and diffusion tensor measured by MRI.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Man between 18 and 55 years
- Confirmed and documented diagnosis of MS, as defined by the revised McDonald criteria
- Patients who have been receiving one of the following diseasemodifying therapies for at least one year prior to randomization: natalizumab , fingolimod, ponesimod, ocrelizumab, or ofatumumab, in accordance with their prescribing information. . Switching from one molecule to another during the previous year is also permitted, provided that the switch was motivated 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 levels below 20 nmol / L (checked by blood sampling during the screening visit)
- For patients under natalizumab :Negative status for JC virus or JC virus synthesis index ≤ 1.5 (within 6 months prior to screening visit)
- No relapses in the year prior to inclusion
You likely can't join if
- Patients with progressive MS (primary or secondary)
- Patients with chronic infectious disease
- Patients with a history of hypersensitivity to Nebido® or any of the excipients, or drugs of similar chemical classes
- Patients who used experimental drugs and / or who participated in clinical drug trials in the 6 months prior to selection
- Patients with hypogonadism with clinical symptoms and treated 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 screening visit)
See the full eligibility criteria
- Man between 18 and 55 years
- Confirmed and documented diagnosis of MS, as defined by the revised McDonald criteria
- Patients who have been receiving one of the following diseasemodifying therapies for at least one year prior to randomization: natalizumab , fingolimod, ponesimod, ocrelizumab, or ofatumumab, in accordance with their prescribing information. . Switching from one molecule to another during the previous year is also permitted, provided that the switch was motivated 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 levels below 20 nmol / L (checked by blood sampling during the screening visit)
- For patients under natalizumab :Negative status for JC virus or JC virus synthesis index ≤ 1.5 (within 6 months prior to screening visit)
- No relapses in the year prior to inclusion
- Stable neurological state in the month preceding randomization
- Patients with progressive MS (primary or secondary)
- Patients with chronic infectious disease
- Patients with a history of hypersensitivity to Nebido® or any of the excipients, or drugs of similar chemical classes
- Patients who used experimental drugs and / or who participated in clinical drug trials in the 6 months prior to selection
- Patients with hypogonadism with clinical symptoms and treated 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 screening visit)
- Patients with a hematocrit level > 54% (checked by blood sampling during the screening visit)
- Patients with any other disease other than MS that may contribute to neurological symptoms and signs or affect their evaluation
- Patients with neurological signs compatible with PML or confirmed PML
- Patients diagnosed with untreated sleep apnea
- Patients with or having had cancer or tumors of the liver, heart, kidney, XML File Identifier: 0bHUQtIJ9JZx4QdRJTxm0++LBOc= Page 12/24 prostate or mammary gland
- Patients with cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, uncontrolled diseases
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.