Phase 2 Multiple Sclerosis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Men aged between 18 and 55 years old
• People who are enrolled in a social health insurance plan
• People who are able to understand the goals and risks of the research and can follow the study requirements for its full duration
• People who have been informed of the results of their pre-study medical check-up
• People who have signed a consent form agreeing to take part
• People with a confirmed and documented diagnosis of multiple sclerosis (MS), based on recognised diagnostic standards called the revised McDonald criteria
• People who have been taking one of the following MS medications for at least one year before joining the trial: natalizumab, fingolimod, ponesimod, ocrelizumab, or ofatumumab — switching between these medications during that year is allowed, as long as the switch was not due to MS getting worse (such as a relapse or new MRI activity); people receiving ocrelizumab for 6 to 9 months may still be eligible if they have been on full-dose ocrelizumab for at least 2 years (confirm with trial site)
• People whose blood test shows low testosterone levels (below 20 nmol/L), confirmed at the screening visit
• People taking natalizumab whose blood test shows they are either negative for a virus called JC virus, or have a JC virus index score of 1.5 or below
• People who have had no MS relapses in the year before joining the trial
• People whose MS disability level, measured by a standard scoring tool called the EDSS, falls between 0 and 7 at the time of the selection visit
• People whose neurological condition has been stable in the month before being assigned to a treatment group

Who may not be able to join:

• People who have a progressive form of MS, either primary or secondary progressive
• People who already have low testosterone with noticeable symptoms and are currently being treated with androgen (testosterone-related) therapy
• People whose prostate-specific antigen (PSA) blood test result is above certain levels — above 2.5 ng/ml for those under 49, or above 3.5 ng/ml for those aged 50 or over
• People whose hematocrit level (a measure of red blood cells in the blood) is above 54%, confirmed by a blood test at the inclusion visit
• People who are unwilling or unable to have an MRI scan
• People who have another condition besides MS that could cause or affect neurological symptoms or how those symptoms are assessed
• People showing neurological signs that may suggest a serious brain condition called progressive multifocal leukoencephalopathy (PML), or who have a confirmed diagnosis of it
• People who have been diagnosed with sleep apnea that is not being treated
• People who have or have had cancer or tumours affecting the liver, heart, kidneys, prostate, or breast tissue
• People with serious uncontrolled conditions affecting the heart, kidneys, liver, blood, digestive system, or lungs
• People who wish to have children during the study period
• People with a long-term (chronic) infectious disease
• People with a physical or mental health condition that affects their ability to understand information or follow the study protocol
• People who have had an allergic reaction to the study treatment, any of its ingredients, or similar types of medication
• People who have taken experimental medications or participated in a clinical drug trial in the 6 months before joining
• People who are currently in an exclusion period from a previous or ongoing clinical study
• People for whom it is not possible to properly provide information — for example, due to an emergency situation or difficulties with understanding
• People who are subject to a legal protection measure, such as guardianship or a similar arrangement

Important: Always verify eligibility with the trial site directly before applying.