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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
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
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Neuroprotection, Remyelination, Relapsing Remitting Multiple sclerosis, Testosterone undecanoate, Diffusion tensor Imaging

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de BesançonRecruiting
  • CHU NancyRecruiting
  • Hôpital Pitié-SalpêtrièreRecruiting
  • CHU de Rennes/PontchaillouRecruiting
  • CHRU de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Testosterone treatment (Nebido®)

Placebo

Arm Description

"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" 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)

Full Information

First Posted
April 1, 2019
Last Updated
March 9, 2023
Sponsor
University Hospital, Strasbourg, France
Collaborators
Bayer, Fédération Hospitalo-Universitaire NEUROGENYCS
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1. Study Identification

Unique Protocol Identification Number
NCT03910738
Brief Title
TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis
Acronym
TOTEM-RRMS
Official Title
TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
Collaborators
Bayer, Fédération Hospitalo-Universitaire NEUROGENYCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Neuroprotection, Remyelination, Relapsing Remitting Multiple sclerosis, Testosterone undecanoate, Diffusion tensor Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 2 trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Testosterone treatment (Nebido®)
Arm Type
Experimental
Arm Description
"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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
"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
Intervention Type
Drug
Intervention Name(s)
Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection
Intervention Description
Active treatment (Nebido® Testosterone Undecanoate ) will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)
Intervention Type
Drug
Intervention Name(s)
Placebo 4 mL Solution for Injection
Intervention Description
Placebo will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
Conventional MS sequences (OFSEP recommendations) and unconventional MRI sequences (Baseline, week 30 and 66)
Intervention Type
Behavioral
Intervention Name(s)
Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities
Intervention Description
BICAMS; SF-36 and EQ-5D-3L; MFIS; HADS; WPAI:MS (at baseline, week 30 and 66)
Intervention Type
Behavioral
Intervention Name(s)
Assessment of disability
Intervention Description
EDSS (Baseline, week 30 and 66)
Primary Outcome Measure Information:
Title
Change on MRI binary criterion combining thalamic atrophy and modification in transverse diffusivity of lesions
Description
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.
Time Frame
At baseline, week 30 and week 66 (end of study)
Secondary Outcome Measure Information:
Title
Evolution of the number of T1 hypointense lesions as detected by conventional MRI
Description
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Evolution of the volume of T1 hypointense lesions as detected by conventional MRIconventional MRI
Description
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Evolution of the number of new or enlarged T2 lesions as detected by conventional MRI
Description
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Evolution of the volume of new or enlarged T2 lesions as detected by conventional MRI
Description
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Evolution of the total volume of hyper-intensity FLAIR lesion as detected by conventional MRI
Description
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Evolution of diffusion tensor imaging (NODDI) as detected by unconventional MRI
Description
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Evolution of quantitative magnetization transfer imaging (MPF) as detected by unconventional MRI
Description
Efficacy will be assessed by comparing results between the 2 groups and in each group between baseline, week 30 and week 66.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Evolution of cognitive performance as measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
Description
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.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Changes in quality of life as measured by the SF-36 questionnaire
Description
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.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Changes in quality of life related to health as measured by the EQ-5D-3L (European Quality of Life in 3 Dimensions) questionnaire.
Description
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.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Changes in work productivity and daily activities due to MS, as assessed by the WPAI:MS questionnaire (Work Productivity and Activity Impairment in MS).
Description
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.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Changes in fatigue, measured by the Multidimensional Fatigue Impact Scale (MFIS)
Description
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.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Changes in anxiety and depression as measured by the Hospital assessment for Anxiety and Depression Scale (HADS) questionnaire
Description
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.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Evolution of disability measured MS specific Expanded Disability Status scale (EDSS)
Description
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.
Time Frame
At baseline, week 30 and week 66 (end of study)
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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)
Time Frame
From Visit 0/baseline to end of study visit (66 weeks)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 receiving for at least 1 year before randomization one of these treatments: 1 intravenous infusion of natalizumab (Tysabri®, 300 mg) every 4 weeks or fingolimod tablets (Gilenya ® 0.5mg) every day or an infusion of ocrelizumab (Ocrevus ® 600mg) every 6 months. Biological hypogonadism defined by serum testosterone levels below 15 nmol / L (checked by blood sampling during the inclusion 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent D KREMER, MD
Phone
+33 3 88 12 87 33
Email
laurentdaniel.kremer@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas COLLONGUES, MD
Phone
+33 3 88 12 87 33
Email
nicolas.collongues@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent D KREMER, MD
Organizational Affiliation
CHU Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric BERGER, MD
Phone
+333 81 66 84 68
Email
eberger@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Eric BERGER, MD
First Name & Middle Initial & Last Name & Degree
Johann BARKATZ, MD
Facility Name
CHU Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume MATHEY, MD
Phone
+333 83 85 16 88
Email
g.mathey@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Guillaume MATHEY, MD
First Name & Middle Initial & Last Name & Degree
Pierre LECOANET, MD
Facility Name
Hôpital Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline Dr LOUAPRE, Dr
Phone
00331 42 16 57 66
Email
celine.louapre@aphp.fr
First Name & Middle Initial & Last Name & Degree
Céline Dr LOUAPRE, Dr
Facility Name
CHU de Rennes/Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure MICHEL, MD
Phone
+332 99 28 42 66
Email
Laure.michel@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Laure MICHEL, MD
First Name & Middle Initial & Last Name & Degree
Anne KERBRAT, MD
First Name & Middle Initial & Last Name & Degree
Andrea MANUNTA, MD
Facility Name
CHRU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent D KREMER, MD
Phone
+333 88 12 87 33
Email
laurentdaniel.kremer@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Nicolas COLLONGUES, MD
Phone
+333 88 12 87 33
Email
nicolas.collongues@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Nicolas COLLONGUES, MD
First Name & Middle Initial & Last Name & Degree
Jérôme DE SEZE, MD
First Name & Middle Initial & Last Name & Degree
Thibault TRICARD, MD
First Name & Middle Initial & Last Name & Degree
Marie Céline FLEURY, MD
First Name & Middle Initial & Last Name & Degree
Livia LANOTTE, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32600454
Citation
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.
Results Reference
derived

Learn more about this trial

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

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