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. - NEMESI-MS Neuroprotection by Memantine at Early Stage In Multiple Sclerosis

Conditions: patients at early stage of relapsing- remitting multiple sclerosis treated with interferon-beta.
MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis

Registration Number: EUCTR2007-000503-15-IT

Lead Sponsor: AZ. OSPEDALIERA GARIBALDI, S.LUIGI CURRO , ASCOLI TOMASELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

Exclusion Criteria

Pregnant, breast-feeding women or those planning pregnancy Primary or secondary epilepsy Serious psychiatric pathologies Alcohol or drug abuse Serious systemic diseases with particular reference to endocrinopathies and metabolic diseases Brain trauma with sequels Depression evaluated according to Beck s scale score 10 Serious impairment and disablement that can interfere with performance of tests

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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;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 Outcome Measures