Ifenprodil as a ReMyelinating repurpOsed Drug in Multiple Sclerosis

Exclusion Criteria

• •Patients
• •1. Patient with an acute NORB in the last 6 months prior to pre-inclusion visit
• •2. Patient with a clinical relapse other than NORB in the last 6 months prior to pre-inclusion visit
• •3. Patients having received methylprednisolone infusion in the last 4 weeks prior to pre-inclusion visit
• •4. Contraindications to investigational medicinal products (ifenprodil/placebo) and to auxiliary medicinal products (gadolinium, \[18F\]-florbetaben)
• •5. Inability to complete an MRI (contraindications for MRI include but are not restricted to weight ≥ 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, contraindication to gadoteric acid etc.).
• •6. PET imaging performed in the past 12 months as part of clinical research
• •7. History or incidental discovery of significant cardiac conduction block
• •8. Orthostatic hypotension Syndrome define as a drop of \> 20 mmHg in systolic, and/or \> 10 mmHg in diastolic between lying down and immediate standing
• •9. Known long QT syndrome or long QT syndrome (the limit is defined at 450 ms on corrected QT) highlighted during the pre-inclusion visit
• •10. Any uncontrolled general (cancer, infectious, hematologic, hepatic, immunologic, endocrinologic, neurologic, dermatologic, psychiatric, allergic, renal, or cardiovascular) disease.
• •11. Creatinine clearance \< 60 ml/min at pre-inclusion visit
• •12. ASAT, ALAT of alkaline phosphatase \> 3-fold the upper limit normal at pre-inclusion visit
• •13. Know Galactosemia, glucose malabsorption or lactase deficiency
• •14. Known of lack of peripheral venous access or lack of peripheral venous access highlighted during the pre-inclusion visit
• •15. Thrombocytopenia with platelets \< 100 000/mm3
• •16. Pregnancy and/or lactating women
• •17. Legal protection (curatorship or tutorship)
• •18. Deprive of freedom or under security measure
• •19. Participation in another interventional trial evaluating a health product or any randomized trial or being in the exclusion period at the end of a previous study
• •20. Refusal to be informed in case of clinically significant incidental discovery after MRI
• •21. Patient treated for hypertension with the following drugs blocking the alpha-adrenergic system either in periphery (prazosine, urapidil, moxisylyte, labetalol) or centrally (clonidine, monoxidine, methyldopa)
• •Healthy Volunteers
• •1. Inability to complete an MRI (contraindications for MRI include but are not restricted to weight ≥ 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc).
• •2. Impossibility to complete a PET scan: pregnancy, nuclear medicine irradiation for clinical research in the year preceding baseline visit.
• •3. Contraindication to auxiliary medicinal products (\[18F\]-florbetaben)
• •4. Known presence of any neurological disorders
• •5. Pregnancy and/or lactation
• •6. Lack of peripheral venous access
• •7. Terminal renal insufficiency (Creatinin clearance \< 60 ml/min)
• •8. Legal protection (curatorship or tutorship)
• •9. Deprive of freedom or under security measure
• •10. Participation in another interventional trial evaluating a health product or any randomized trial or being in the exclusion period at the end of a previous study
• •11. Refusal to be informed in case of clinically significant incidental discovery after MRI