TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis
NCT ID: NCT03910738
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2019-10-29
2027-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Testosterone treatment (Nebido®)
"Treatment/Nebido®" arm: in this experimental arm, each patient will be injected intramuscularly with 1000 mg / 4 ml of testosterone undecanoate (Nebido®).
Treatment will be injected at baseline, week 6, 18, 30, 42 and 54
Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection
Active treatment (Nebido® Testosterone Undecanoate ) will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)
MRI
Conventional MS sequences (OFSEP recommendations) and unconventional MRI sequences (Baseline, week 30 and 66)
Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities
BICAMS; SF-36 and EQ-5D-3L; MFIS; HADS; WPAI:MS (at baseline, week 30 and 66)
Assessment of disability
EDSS (Baseline, week 30 and 66)
Placebo
"Placebo" arm: In this arm, each patient will be injected intramuscularly with 4 ml of placebo solution.
Placebo will be injected at baseline, week 6, 18, 30, 42 and 54
Placebo 4 mL Solution for Injection
Placebo will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)
MRI
Conventional MS sequences (OFSEP recommendations) and unconventional MRI sequences (Baseline, week 30 and 66)
Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities
BICAMS; SF-36 and EQ-5D-3L; MFIS; HADS; WPAI:MS (at baseline, week 30 and 66)
Assessment of disability
EDSS (Baseline, week 30 and 66)
Interventions
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Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection
Active treatment (Nebido® Testosterone Undecanoate ) will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)
Placebo 4 mL Solution for Injection
Placebo will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)
MRI
Conventional MS sequences (OFSEP recommendations) and unconventional MRI sequences (Baseline, week 30 and 66)
Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities
BICAMS; SF-36 and EQ-5D-3L; MFIS; HADS; WPAI:MS (at baseline, week 30 and 66)
Assessment of disability
EDSS (Baseline, week 30 and 66)
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
55 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Fédération Hospitalo-Universitaire NEUROGENYCS
UNKNOWN
Grünenthal GmbH
INDUSTRY
University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Laurent D KREMER, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Strasbourg
Locations
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CHU de Besançon
Besançon, , France
CHU Nancy
Nancy, , France
Hôpital Pitié-Salpêtrière
Paris, , France
CHU de Rennes/Pontchaillou
Rennes, , France
CHRU de Strasbourg
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Metzger-Peter K, Kremer LD, Edan G, Loureiro De Sousa P, Lamy J, Bagnard D, Mensah-Nyagan AG, Tricard T, Mathey G, Debouverie M, Berger E, Kerbrat A, Meyer N, De Seze J, Collongues N. The TOTEM RRMS (Testosterone Treatment on neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis) trial: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2020 Jun 29;21(1):591. doi: 10.1186/s13063-020-04517-6.
Other Identifiers
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7109
Identifier Type: -
Identifier Source: org_study_id
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