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New treatment option for Multiple Sclerosis, Relapsing-Remitting
Official title TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis
ClinicalTrials.gov ID: NCT03910738
What this study is testing
What is Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection?
Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection is an investigational medicine, being studied as a potential treatment for multiple sclerosis, relapsing-remitting.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, men only
You may be able to join if
- 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...
- Patient having been informed of the results of the prior medical examination
- Patient having signed an informed consent
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Nancy, France
- Paris, France
- Rennes, France
- Strasbourg, France
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 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Nancy, France; Paris, France; Rennes, France; Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.