Testosterone treatment for neuroprotection and myelin repair in relapsing remitting multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Slip-and-trip motor training to reduce falls in relapsing‑remitting multiple sclerosis

  This program tests whether repeated practice with controlled slips and trips helps ambulatory adults with relapsing‑remitting multiple sclerosis learn to react better and lower their chance of falling.

  Recruiting Georgia State University · Atlanta, Georgia · NCT06919900

• Effects of Ketogenic Diet on Multiple Sclerosis

  This study is testing whether a ketogenic diet or a Mediterranean diet can help people with relapsing-remitting multiple sclerosis feel better and manage their symptoms.

  Recruiting IRCCS National Neurological Institute "C. Mondino" Foundation · Pavia · NCT06715436

• Using magnetic stimulation to reduce fatigue in multiple sclerosis

  This study is testing if a type of magnetic stimulation can help reduce fatigue in people with Relapsing-Remitting Multiple Sclerosis.

  Recruiting Danish Research Centre for Magnetic Resonance · Hvidovre, Capital Region · NCT06569550

• Treatment for Multiple Sclerosis Using Stem Cell Transplantation

  This study is testing the long-term effects of a stem cell treatment for people with active relapsing-remitting multiple sclerosis to see how it impacts their health over five years.

  Recruiting at 2 sites Amsterdam UMC, location VUmc · Amsterdam and 1 other locations · NCT06567197

• Observational study of patients with Multiple Sclerosis in Switzerland

  This study is trying to find out more about the early signs of Multiple Sclerosis and how it changes over time by looking at health data from patients in Switzerland.

  Recruiting University Hospital, Basel, Switzerland · Basel · NCT06526364

• Evaluating Ozanimod versus Fingolimod for Children with Relapsing Remitting Multiple Sclerosis

  This study is testing whether ozanimod works better than fingolimod for children and teens with relapsing remitting multiple sclerosis.

  Recruiting at 20 sites Phase 3 Bristol-Myers Squibb · Loma Linda, California and 32 other locations · NCT06408259

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.