Relapsing Remitting Multiple sclerosis MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: NEBIDO
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Testosterone
Other descriptive name: TESTOSTERONE UNDECANOATE
Concentration unit: mg/ml milligram(s)/millilitre
Conc
Sponsors
Hôpitaux Universitaires de Strasbourg
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Man between 18 and 55 years - 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 prior to randomization - Biological hypogonadism defined by serum total testosterone levels below 15 nmol / L (checked by blood sampling during the screening visit) - Negative status for JC virus or JC virus synthesis index = 1.5 (within 6 months prior to screening 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 screening visit) - Patients with a hemoglobin concentration> 16 g / dL (checked by blood sampling during the screening visit) - 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 PML or confirmed PML - 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 with chronic infectious disease - Patients with a history of hypersensitivity to Nebido® 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the remyelinating and neuroprotective effect of testosterone treatment used for 54 weeks in natalizumab-treated RRMS patients (Tysabri®) using a combination of thalamus atrophy and diffusion tensor measured by MRI.;Secondary Objective: - To Evaluate the effectiveness of the treatment on advanced parameters in MRI. - To evaluate the clinical effectiveness of the treatment and its tolerance.;Primary end point(s): Binary criterion comparing the success rate in each treatment group, defined by thalamic atrophy less than 0.5% per year and / or a decrease in transverse diffusivity in lesions less than 0.5% per year.;Timepoint(s) of evaluation of this end point: After 54 weeks of study drug (Visit 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficiency of treatment by imaging: • evolution of conventional MRI parameters: volume and number of T1 hypointense lesions, volume and number of new or enlarged T2 lesions, total volume of hyper-intensity FLAIR. • evolution of unconventional MRI parameters: diffusion tensor imaging (NODDI), quantitative magnetization transfer imaging (MPF). Clinical efficiency of treatment: • Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) test consisting of the symbol digit modalities test (SDMT), the California Verbal Learning Test Second Edition (CVLT2), and the Brief Visuospatial Memory Test Revised (BVMTR) test, • Changes in quality of life and health-related quality of life as measured by the SF-36 and EQ-5D (European quality of life in 5 dimensions) questionnaires respectively. • Impact of MS on workplace productivity and day-to-day activities, as assessed by the WPAI (Work productivity and activity impairment) questionnaire. • Impact on fatigue, as measured by the Multi-Dimensional Fatigue Impact Scale (MFIS), • Hospital assessment scale for anxiety and depression, as measured by the hospital anxiety and depression scale (HADS) questionnaire. • Evolution of handicap by the EDSS Score Safe use of the treatment: number and nature of adverse events, evaluation of vital signs at each visit, clinical and neurological examinations, biological results, locally interpreted MRI for tolerance (non-MS pathology of the CNS) and monitoring of concomitant medications ( outside Tysabri®).;Timepoint(s) of evaluation of this end point: After 54 weeks of study drug (Visit 6) | — |
Countries
France
Contacts
Public ContactEric DEMONSANT
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed