Study on Testosterone Undecanoate for Neuroprotection and Myelin Repair in Patients with Relapsing Remitting Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Relapsing Remitting Multiple Sclerosis (RRMS), a type of multiple sclerosis characterized by periods of new or increasing symptoms followed by periods of remission. The treatment being tested is NEBIDO, which contains the active substance testosterone undecanoate. This medication is administered as a solution for injection. The study also involves a comparison with a placebo, which is a substance with no active therapeutic effect.

The purpose of the study is to evaluate whether testosterone treatment can help protect nerve cells and repair the protective covering of nerves, known as myelin, in patients with RRMS. Participants in the study will receive the treatment for a period of 54 weeks. During this time, they will continue their existing treatment with one of the following medications: natalizumab, fingolimod, ponesimod, ocrelizumab, or ofatumumab. These medications are known as disease-modifying therapies, which help manage the symptoms and progression of multiple sclerosis.

Throughout the study, participants will undergo regular assessments, including MRI scans, to monitor changes in the brain and evaluate the treatment’s impact on the disease. The study aims to determine if the treatment can reduce brain tissue loss and improve nerve function. Participants will also complete various questionnaires to assess their cognitive function, quality of life, and the impact of the disease on their daily activities. The safety of the treatment will be closely monitored by evaluating any side effects and conducting regular health checks.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of multiple sclerosis, and current treatment regimen.

A blood test is conducted to check testosterone levels, ensuring they are below 20 nmol/L.

2 initial assessment

An initial assessment is performed, including a review of medical history and a neurological examination.

MRI scans are conducted to evaluate brain structure and function.

3 treatment phase

The treatment involves the administration of NEBIDO 1000 mg/4 ml, a solution for injection containing testosterone undecanoate.

The medication is given through an intramuscular injection every 12 weeks for a total duration of 54 weeks.

4 ongoing monitoring

Regular follow-up visits are scheduled to monitor health status, including clinical and neurological examinations.

MRI scans are repeated to assess changes in brain structure and function.

5 final assessment

At the end of the 54-week treatment period, a final assessment is conducted.

This includes a comprehensive review of all clinical data, MRI results, and any side effects experienced during the trial.

Who Can Join the Study?

Must be a man between the ages of 18 and 55.
Must have a confirmed and documented diagnosis of Multiple Sclerosis (MS) according to specific criteria known as the revised McDonald criteria.
Must have been receiving one of the following treatments for at least one year before joining the study: natalizumab, fingolimod, ponesimod, ocrelizumab, or ofatumumab. Switching between these treatments in the past year is allowed if the change was not due to a worsening of neurological symptoms.
Must have biological hypogonadism, which means having low levels of testosterone in the blood, specifically below 20 nmol/L. This will be checked with a blood test during the screening visit.
If taking natalizumab, must have a negative status for the JC virus or a JC virus synthesis index of 1.5 or less, checked within 6 months before the screening visit.
Must not have had any relapses (worsening of symptoms) in the year before joining the study.
Must have a stable neurological condition in the month before joining the study.

Who Cannot Join the Study?

Patients who are not male cannot participate in the study.
Patients who are not within the specified age range cannot participate in the study.
Patients who are part of a vulnerable population cannot participate in the study.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier Regional Universitaire	Besançon	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Cdoi Dn Neghd	Vandoeuvre Les Nancy	France
Htjxipnz Uprjrplisgexgs Srrqyfgobx &rztjku Hggnwjg dn Hohwgwdwrrp	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	29.10.2019

Trial locations

Investigated drugs:

Testosterone Undecanoate

Testosterone is being studied for its potential to protect nerves and repair myelin in patients with relapsing-remitting multiple sclerosis (RRMS). The trial aims to see if testosterone can help reduce brain damage and improve nerve function over a period of 54 weeks.

Natalizumab is a medication used to treat RRMS by preventing immune cells from entering the brain and spinal cord, which may help reduce inflammation and slow the progression of the disease.

Fingolimod is another treatment for RRMS that works by trapping certain immune cells in the lymph nodes, preventing them from reaching the brain and spinal cord, thereby reducing inflammation and disease activity.

Ponesimod is used in RRMS to reduce the number of relapses by modulating the immune system and preventing certain immune cells from causing damage to the nervous system.

Ocrelizumab is a medication that targets specific immune cells, helping to reduce inflammation and slow the progression of RRMS by decreasing the frequency of relapses.

Ofatumumab is used in the treatment of RRMS to target and deplete specific immune cells, which helps in reducing inflammation and the frequency of relapses, potentially slowing disease progression.

Investigated diseases:

Relapsing-remitting multiple sclerosis

Relapsing-Remitting Multiple Sclerosis – This is a type of multiple sclerosis characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery. During relapses, patients may experience symptoms such as vision problems, muscle weakness, and coordination difficulties. These symptoms can vary in severity and duration. Between relapses, the disease does not progress, and patients may have no symptoms or only mild ones. Over time, some individuals may transition to a secondary progressive form of the disease, where symptoms gradually worsen. The exact cause of this condition is not fully understood, but it involves an immune system attack on the protective covering of nerves.

Trial ID:

2024-517845-14-00

Protocol code:

7109

NCT ID:

NCT03910738

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Testosterone Undecanoate for Neuroprotection and Myelin Repair in Patients with Relapsing Remitting Multiple Sclerosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?