Testosterone undecanoate for Relapsing-remitting multiple sclerosis

Inclusion criteria

• {"criterion_text":"- Man between 18 and 55 years"}
• {"criterion_text":"- Confirmed and documented diagnosis of MS, as defined by the revised McDonald criteria"}
• {"criterion_text":"- Patients who have been receiving one of the following diseasemodifying 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\"."}
• {"criterion_text":"- Biological hypogonadism defined by serum total testosterone levels below 20 nmol / L (checked by blood sampling during the screening visit)"}
• {"criterion_text":"- For patients under natalizumab :Negative status for JC virus or JC virus synthesis index ≤ 1.5 (within 6 months prior to screening visit)"}
• {"criterion_text":"- No relapses in the year prior to inclusion"}
• {"criterion_text":"- Stable neurological state in the month preceding randomization"}

Exclusion criteria

• {"criterion_text":"- Patients with progressive MS (primary or secondary)"}
• {"criterion_text":"- Patients with chronic infectious disease"}
• {"criterion_text":"- Patients with a history of hypersensitivity to Nebido® or any of the excipients, or drugs of similar chemical classes"}
• {"criterion_text":"- Patients who used experimental drugs and / or who participated in clinical drug trials in the 6 months prior to selection"}
• {"criterion_text":"- Patients with hypogonadism with clinical symptoms and treated with androgens"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Patients with a hematocrit level > 54% (checked by blood sampling during the screening visit)"}
• {"criterion_text":"- Patients with any other disease other than MS that may contribute to neurological symptoms and signs or affect their evaluation"}
• {"criterion_text":"- Patients with neurological signs compatible with PML or confirmed PML"}
• {"criterion_text":"- Patients diagnosed with untreated sleep apnea"}
• {"criterion_text":"- Patients with or having had cancer or tumors of the liver, heart, kidney, XML File Identifier: 0bHUQtIJ9JZx4QdRJTxm0++LBOc= Page 12/24 prostate or mammary gland"}
• {"criterion_text":"- Patients with cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, uncontrolled diseases"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Defined by thalamic atrophy < 0.5% per year and/or decrease in transverse diffusivity in lesions < 0.5% per year; measured by MRI (analysis of thalamus atrophy and diffusion tensor imaging)."}

Secondary endpoints

• {"endpoint_text":"- Efficiency of treatment by imaging: XML File Identifier: 0bHUQtIJ9JZx4QdRJTxm0++LBOc= Page 13/24 • 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).","definition_or_measurement_approach":"MRI-based measures: conventional MRI parameters (T1 hypointense lesion volume/number, new/enlarged T2 lesion volume/number, total FLAIR hyper-intensity volume) and unconventional parameters (diffusion tensor imaging NODDI, quantitative magnetization transfer MPF)."}
• {"endpoint_text":"- Clinical efficiency of treatment: • Brief International Cognitive Assessment for Multiple Sclerosis, test consisting of the symbol digit modalities test, the California Verbal Learning Test Second Edition, and the Brief Visuospatial Memory Test Revised test • Changes in quality of life and health-related quality of life as measured by the SF-36 and EQ-5D questionnaires respectively.","definition_or_measurement_approach":"Clinical assessments: Brief International Cognitive Assessment for MS (SDMT, CVLT-II, BVMT-R); quality of life measured by SF-36 and EQ-5D."}
• {"endpoint_text":"- Clinical efficiency of treatment: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),","definition_or_measurement_approach":"Patient-reported outcomes: WPAI questionnaire for work productivity/activity impairment; fatigue measured by the Multi-Dimensional Fatigue Impact Scale (MFIS)."}
• {"endpoint_text":"- Clinical efficiency of treatment: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","definition_or_measurement_approach":"Psychological/neurological scales: HADS for anxiety/depression; EDSS score for disability progression."}
• {"endpoint_text":"- 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®).","definition_or_measurement_approach":"Safety monitoring: adverse events reporting; vital signs; clinical/neurological exams; laboratory tests; locally interpreted MRI for non-MS CNS pathology; monitoring concomitant medications."}

France

Earliest CTIS Part Ii Submission Date

12-09-2024

Latest Decision Or Authorization Date

16-06-2025

Processing Time Days

277

Number Of Sites

5

Number Of Participants

80

Primary sponsor

Full Name

Les Hopitaux Universitaires De Strasbourg

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France