Multiple Sclerosis, Relapsing-RemittingPhase 2TOTEM-RRMSNCT03910738
TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis
A Phase 2 study testing Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection, MRI and Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities in people with Multiple Sclerosis, Relapsing-Remitting, run by University Hospital, Strasbourg, France at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection, MRI and Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 5 sitesFrance
- Study dates
- 29 Oct 2019to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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,
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Eric BERGER, MD, +333 81 66 84 68, eberger@chu-besancon.fr
Eric BERGER, MD
- Recruiting
CHU Nancy
Nancy, 54000
Guillaume MATHEY, MD, +333 83 85 16 88, g.mathey@chru-nancy.fr
Guillaume MATHEY, MD
- Recruiting
Hôpital Pitié-Salpêtrière
Paris, 75013
Céline Dr LOUAPRE, Dr, 00331 42 16 57 66, celine.louapre@aphp.fr
Céline Dr LOUAPRE, Dr
- Recruiting
CHU de Rennes/Pontchaillou
Rennes, 35000
Laure MICHEL, MD, +332 99 28 42 66, Laure.michel@chu-rennes.fr
Laure MICHEL, MD
- Recruiting
CHRU de Strasbourg
Strasbourg, 67000
Laurent D KREMER, MD, +333 88 12 87 33, laurentdaniel.kremer@chru-strasbourg.fr
Nicolas COLLONGUES, MD, +333 88 12 87 33, nicolas.collongues@chru-strasbourg.fr
About this study
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.
Read more
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).
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection, Placebo 4 mL Solution for Injection, MRI, Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities, Assessment of disability
- Keywords
- Neuroprotection, Remyelination, Relapsing Remitting Multiple sclerosis, Testosterone undecanoate, Diffusion tensor Imaging
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for InjectionDrug
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 InjectionDrug
Placebo will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)
MRIProcedure or surgery
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 activitiesBehavioural
BICAMS; SF-36 and EQ-5D-3L; MFIS; HADS; WPAI:MS (at baseline, week 30 and 66)
Assessment of disabilityBehavioural
EDSS (Baseline, week 30 and 66)
| Study group | Role | What they receive |
|---|---|---|
| Testosterone treatment (Nebido®) | Experimental | "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 Receives: Drug: Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection; Procedure: MRI; Behavioral: Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities; Behavioral: Assessment of disability |
| Placebo | Placebo comparator | "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 Receives: Drug: Placebo 4 mL Solution for Injection; Procedure: MRI; Behavioral: Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities; Behavioral: Assessment of disability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on MRI binary criterion combining thalamic atrophy and modification in transverse diffusivity of lesions
The primary endpoint is a binary criterion comparing the success rate in each treatment group, defined by thalamic atrophy lower than 0.5% and modification in transverse diffusivity of lesions lower than 0.5% per year compared between baseline and week 66 in each group.
Measured: At baseline, week 30 and week 66 (end of study)
Secondary outcomes (15)
Evolution of the number of T1 hypointense lesions as detected by conventional MRI
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Evolution of the volume of T1 hypointense lesions as detected by conventional MRIconventional MRI
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Evolution of the number of new or enlarged T2 lesions as detected by conventional MRI
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Evolution of the volume of new or enlarged T2 lesions as detected by conventional MRI
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Evolution of the total volume of hyper-intensity FLAIR lesion as detected by conventional MRI
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Evolution of diffusion tensor imaging (NODDI) as detected by unconventional MRI
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Evolution of quantitative magnetization transfer imaging (MPF) as detected by unconventional MRI
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Evolution of cognitive performance as measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
BICAMS is a composite cognitive assessment tool comprising of the three components: Symbol Digit Modalities Test (SDMT), California Verbal Learning Test-II (CVLT-II) and Brief visuospatial memory test- Revised (BVMT-R). Efficacy will be assessed by comparing the composite score between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Changes in quality of life as measured by the SF-36 questionnaire
SF-36 questionnaire is a 36-item Short Form survey designed to examine the perceived health status measured in eight health concepts. Answers to each question are scored and summed to produce raw scale scores for each health concept. Efficacy will be assessed by comparing scores between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Changes in quality of life related to health as measured by the EQ-5D-3L (European Quality of Life in 3 Dimensions) questionnaire.
EQ-5D-3L is a standardized instrument used as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Efficacy will be assessed by comparing the composite scores between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Changes in work productivity and daily activities due to MS, as assessed by the WPAI:MS questionnaire (Work Productivity and Activity Impairment in MS).
WPAI questionnaire measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteeism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Efficacy will be assessed by comparing score between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Changes in fatigue, measured by the Multidimensional Fatigue Impact Scale (MFIS)
MFIS is a 21-item questionnaire that assesses overall self-reported fatigue. Subjects rate agreement with a series of statements on a scale of 0 (rarely) to 4 (almost always), in context of their fatigue over the preceding four weeks. Total possible score of 84. Individuals with an MFIS score of > 38 are considered to experience moderate to severe "fatigue". Efficacy will be assessed by comparing score between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Changes in anxiety and depression as measured by the Hospital assessment for Anxiety and Depression Scale (HADS) questionnaire
HADS is a 14-item self-rating scale that assesses anxiety and depression. Each question is scored on a scale ranging from 0 to 3. Responses are summed to provide separate scores for anxiety and depression that range from 0 to 21. For each corresponding subscale, a total score of 0-7 equals normal, 8-10 equals borderline case, and 11-21 equals case. Efficacy will be assessed by comparing score between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Evolution of disability measured MS specific Expanded Disability Status scale (EDSS)
EDSS measures disability status on a scale ranging from 0 to 10, in eight functional system scale: motor, sensory, cerebellar, brain stem, visual, mental, sphincter and other systems. The EDSS is formed on the score in each functional system; higher scores indicating more disability (0 = normal examination and 10= death from MS). Efficacy will be assessed by comparing score between the 2 groups and in each group between baseline, week 30 and week 66.
Measured: At baseline, week 30 and week 66 (end of study)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety of treatment will be followed by the number and type of adverse or severe adverse events (AE/SAE) throughout the protocol (from baseline to week 66)
Measured: From Visit 0/baseline to end of study visit (66 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start29 Oct 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 2 trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Fédération Hospitalo-Universitaire NEUROGENYCS, Grünenthal GmbH
- Responsible party
- Sponsor
- Investigators
- Laurent D KREMER, MD, Principal investigator, CHU Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910738
- Sponsor's protocol ID
- 7109
- Acronym
- TOTEM-RRMS
- Status last verified
- Jun 2025
- First submitted
- 1 Apr 2019
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32600454
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03910738
- Acronym / sponsor ID
- TOTEM-RRMS / 7109
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Neuroprotection, Remyelination, Relapsing Remitting Multiple sclerosis, Testosterone undecanoate, Diffusion tensor Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Bayer, Fédération Hospitalo-Universitaire NEUROGENYCS, Grünenthal GmbH
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 2 trial
| Arm | Type | Receives |
|---|---|---|
| Testosterone treatment (Nebido®) | Experimental | Drug: Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection, Procedure: MRI, Behavioral: Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities, Behavioral: Assessment of disability"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 |
| Placebo | Placebo comparator | Drug: Placebo 4 mL Solution for Injection, Procedure: MRI, Behavioral: Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities, Behavioral: Assessment of disability"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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for InjectionActive treatment (Nebido® Testosterone Undecanoate ) will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54) | Drug | Testosterone treatment (Nebido®) |
| Placebo 4 mL Solution for InjectionPlacebo will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54) | Drug | Placebo |
| MRIConventional MS sequences (OFSEP recommendations) and unconventional MRI sequences (Baseline, week 30 and 66) | Procedure or surgery | Placebo, Testosterone treatment (Nebido®) |
| Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activitiesBICAMS; SF-36 and EQ-5D-3L; MFIS; HADS; WPAI:MS (at baseline, week 30 and 66) | Behavioural | Placebo, Testosterone treatment (Nebido®) |
| Assessment of disabilityEDSS (Baseline, week 30 and 66) | Behavioural | Placebo, Testosterone treatment (Nebido®) |
Primary outcome
Change on MRI binary criterion combining thalamic atrophy and modification in transverse diffusivity of lesions
Time frame: At baseline, week 30 and week 66 (end of study)
The primary endpoint is a binary criterion comparing the success rate in each treatment group, defined by thalamic atrophy lower than 0.5% and modification in transverse diffusivity of lesions lower than 0.5% per year compared between baseline and week 66 in each group.
15 secondary outcomes
Evolution of the number of T1 hypointense lesions as detected by conventional MRI
Time frame: At baseline, week 30 and week 66 (end of study)
Evolution of the volume of T1 hypointense lesions as detected by conventional MRIconventional MRI
Time frame: At baseline, week 30 and week 66 (end of study)
Evolution of the number of new or enlarged T2 lesions as detected by conventional MRI
Time frame: At baseline, week 30 and week 66 (end of study)
Evolution of the volume of new or enlarged T2 lesions as detected by conventional MRI
Time frame: At baseline, week 30 and week 66 (end of study)
Evolution of the total volume of hyper-intensity FLAIR lesion as detected by conventional MRI
Time frame: At baseline, week 30 and week 66 (end of study)
Evolution of diffusion tensor imaging (NODDI) as detected by unconventional MRI
Time frame: At baseline, week 30 and week 66 (end of study)
Evolution of quantitative magnetization transfer imaging (MPF) as detected by unconventional MRI
Time frame: At baseline, week 30 and week 66 (end of study)
Evolution of cognitive performance as measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
Time frame: At baseline, week 30 and week 66 (end of study)
Changes in quality of life as measured by the SF-36 questionnaire
Time frame: At baseline, week 30 and week 66 (end of study)
Changes in quality of life related to health as measured by the EQ-5D-3L (European Quality of Life in 3 Dimensions) questionnaire.
Time frame: At baseline, week 30 and week 66 (end of study)
Changes in work productivity and daily activities due to MS, as assessed by the WPAI:MS questionnaire (Work Productivity and Activity Impairment in MS).
Time frame: At baseline, week 30 and week 66 (end of study)
Changes in fatigue, measured by the Multidimensional Fatigue Impact Scale (MFIS)
Time frame: At baseline, week 30 and week 66 (end of study)
Changes in anxiety and depression as measured by the Hospital assessment for Anxiety and Depression Scale (HADS) questionnaire
Time frame: At baseline, week 30 and week 66 (end of study)
Evolution of disability measured MS specific Expanded Disability Status scale (EDSS)
Time frame: At baseline, week 30 and week 66 (end of study)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From Visit 0/baseline to end of study visit (66 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Derived from this study: PubMed 32600454Metzger-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.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis, Relapsing-Remitting
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent D KREMER, MD principal investigator
CHU Strasbourg
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection, MRI and Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities in people with Multiple Sclerosis, Relapsing-Remitting, run by University Hospital, Strasbourg, France at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent D KREMER, MD (+333 88 12 87 33, laurentdaniel.kremer@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on MRI binary criterion combining thalamic atrophy and modification in transverse diffusivity of lesions (time frame: At baseline, week 30 and week 66 (end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03910738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.