Experimental clinical open study, randomized, experimental group vs control group, for the evaluation of tolerability and the effects on magnetic resonance parameters and cognitive functions of memantine in patients at early stage of relapsing- remitting multiple sclerosis treated with interferon-beta.

INTERVENTION: Trade Name: EBIXA Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Memantine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ CONDITION: patients at early stage of relapsing‐ remitting multiple sclerosis treated with interferon‐beta. ; MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis PRIMARY OUTCOME: Main Objective: To evaluate treatment effects on MRI parameters more directly related to irreversible neurological damage; To evaluate the effects of the therapy on the cognitive sphere. Primary end point(s): Percentage of reduction in whole brain volume. Percentage of reduction in regional brain volume. Number and volume of new T1 lesions black holes Secondary Objective: To evaluate the tolerability of a treatment with memantine 10 mg b.i.d. in patients treated with IFN‐beta. To evaluate treatment effects on other MRI parameters more directly related to the inflammatory activity of the disease INCLUSION CRITERIA: Onset of IFN‐beta treatment within 3 months Diagnosis of clinically defined Multiple Sclerosis within 2 years according to McDonald s criteria Aged between 18 and 50 years EDSS 8804;3.5 Free from corticosteroids since at least 60 days, from immunosuppressors since at least 6 months and free of other immunomodulators since at least 2 months prior to enrollmentPatients willing to sign informed consent Patients with Beck Depression score 8804;10 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range