Testosterone treatment for neuroprotection and myelin repair in relapsing remitting multiple sclerosis
TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis
This study is testing if testosterone treatment can help protect nerves and repair myelin in men with relapsing-remitting multiple sclerosis who have low testosterone levels.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Male |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Drugs / interventions | natalizumab, ocrelizumab, ofatumumab |
| Locations | 5 sites (Besançon and 4 other locations) |
| Trial ID | NCT03910738 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of testosterone undecanoate on neuroprotection and myelin repair in patients with relapsing-remitting multiple sclerosis (RRMS). It is a multicenter, randomized, double-blind, placebo-controlled phase 2 trial aimed at assessing the potential benefits of testosterone supplementation in testosterone-deficient men aged 18 to 55 who have been on disease-modifying therapies. The study will evaluate cognitive impact, quality of life, fatigue, anxiety/depression, and disability through various assessments, including MRI. The goal is to explore innovative therapies that promote neuroregeneration and myelin repair, addressing a critical need in MS treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 18 to 55 with a confirmed diagnosis of relapsing-remitting multiple sclerosis who have been on specific disease-modifying therapies for at least one year.
Not a fit: Patients who are not men, those outside the age range of 18 to 55, or those without a confirmed diagnosis of relapsing-remitting multiple sclerosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance neuroprotection and promote myelin repair in patients with relapsing-remitting multiple sclerosis.
How similar studies have performed: While there have been few exploratory trials on testosterone in this context, this approach is relatively novel and has not been extensively tested in a similar structured manner.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Man between 18 and 55 years * Patient affiliated to a social health insurance plan * Patient able to understand the objectives and risks related to the research and able to comply with the requirements of the protocol throughout the duration of the study * Patient having been informed of the results of the prior medical examination * Patient having signed an informed consent * Confirmed and documented diagnosis of MS, as defined by the revised McDonald criteria, * Patient who have been receiving one of the following disease modifying 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 (checked by blood sampling at the inclusion visit) * No relapses in the year prior to inclusion * Disability status during the selection visit with an EDSS score of 0 to 7 (verified by questionnaire during the inclusion visit) * Stable neurological state in the month preceding randomization Exclusion Criteria: * Patients with progressive MS (primary or secondary) * 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 the inclusion visit) * Patients with a hematocrit level \> 54% (checked by blood sampling during the inclusion visit) * Patients refusing or unable to undergo an MRI * 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 progressive multifocal leukoencephalopathy (PML) or confirmed leukoencephalopathy * Patients diagnosed with untreated sleep apnea * Patients with or having had cancer or tumors of the liver, heart, kidney, prostate or mammary gland * Patients with cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, uncontrolled diseases * Patients wishing to procreate during the study period * Patients with chronic infectious disease * Patients with organic or psychiatric disease compromise their ability to understand the information given and to follow the protocol * Patients with a history of hypersensitivity to treatment 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 * Patient in exclusion period (determined by previous study or in progress) * Impossibility of giving information to the patient (subject in emergency situation, difficulties in understanding the subject or other) * Incapacitated subject (subject to a legal protection measure: safeguard of justice, curatorship, guardianship, future protection mandate, family habilitation)
Where this trial is running
Besançon and 4 other locations
- CHU de Besançon — Besançon, France (Recruiting)
- CHU Nancy — Nancy, France (Recruiting)
- Hôpital Pitié-Salpêtrière — Paris, France (Recruiting)
- CHU de Rennes/Pontchaillou — Rennes, France (Recruiting)
- CHRU de Strasbourg — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Laurent D KREMER, MD — CHU Strasbourg
- Study coordinator: Laurent D KREMER, MD
- Email: laurentdaniel.kremer@chru-strasbourg.fr
- Phone: +333 88 12 87 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.