TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis

  • STATUS
    Recruiting
  • End date
    May 25, 2023
  • participants needed
    40
  • sponsor
    University Hospital, Strasbourg, France
Updated on 25 October 2021
depression
fatigue
natalizumab
demyelination
tysabri
relapsing multiple sclerosis

Summary

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. However, there is an urgent need for innovative therapies promoting neuroregeneration and particularly myelin repair.

It has been demonstrated that testosterone can act through neural androgen receptors to promote proliferation and differentiation of oligodendrocyte precursors into mature oligodendrocytes in a cuprizone-induced animal model of demyelination. The rare clinical trials on testosterone are mainly exploratory. Here, we sought to demonstrate an effect of testosterone supplementation in testosterone-deficient patients in a multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 2 trial.

The main objective will be to determine the neuroprotective and remyelinating effects of testosterone using tensor diffusion imaging techniques and thalamic atrophy analyzes.

As secondary objectives, we would like to study the impact of testosterone supplementation on other conventional and unconventional MRI parameters and on clinical outcomes (cognition, fatigue, quality of life, impact on work / activity and anxiety / depression).

Details
Condition relapsing-remitting multiple sclerosis
Treatment MRI, Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection, Placebo 4 mL Solution for Injection, Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities, Assessment of disability
Clinical Study IdentifierNCT03910738
SponsorUniversity Hospital, Strasbourg, France
Last Modified on25 October 2021

Eligibility

Yes No Not Sure

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 treated with intravenous infusions of natalizumab (Tysabri, 300 mg) once every 4 weeks for at least 1 year
Biological hypogonadism defined by serum testosterone levels below 15 nmol / L (checked by blood sampling during the inclusion visit)
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 hemoglobin concentration> 16 g / dL (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)
Patients under tutors or curators
Patients under the protection of justice
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note