Study on Cognitive Disorders of Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if memantine is effective in the treatment on cognitive disorders of Relapsing - Remitting multiple sclerosis. m

Official Title
-----------------
Effects of Memantine on Cognitive Disorders of Relapsing-remitting Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Memantine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Remitting Multiple Sclerosis defined by Mc Donald et al., 2001 Patient with authorised immunomodulator treatment or oral immunosuppressive therapy during more than three months: Bétâ Interferon, glatiramer acetate, azathioprine, methotrexate, mycophenolate mofetil, treatment by monoclonal antibody I.V. or anti-VLA4, natalizumab (Tysabri) Patient having benefited, possibly, of following treatments : mitoxantrone, cyclophosphamide, cyclosporine, general-purpose immunoglobulins, only if the treatment is ended more of 6 months before the inclusion. EDSS score ≤ 5.5 DRS score ≥ 130 PASAT 3s score > 15 and < median / control subjects according to 2 age brackets, sex, school level. Signed the informed consent form. Effective contraception for women in age to procreate Exclusion Criteria: Progressive form MS MS relapse of less of 4 weeks. IV or oral corticoid treatment in the month preceding the screening Medicinal treatments or non medicinal in cognitive or psychology-stimulant aim in the 3 months before the screening Tumoral form MS visible in the MRI. Depressive syndrome (MADRS score > 19). Quite other diagnosed psychiatric pathology Known allergy or quite contraindication in memantin : renal or hepatic insufficiency, turned out epileptic disease, treatment by ketamine, amantadin, dextromethorphan, L-Dopa, dopaminergic agonist, barbituric, neuroleptic, 3,4-diaminopyridine, lithium, cimetidine, ranitidine, procainamide, quinine, nicotine, hydrochlorthiazide and ally, phenytoin, modafinil. Recent treatment (less of 4 weeks) by antidepressants and/or anxiolytics. Pregnancy or feeding. Minor or Major protected by the law patient Uncontrolled diet. Patient having benefited of one psychometric assessment(including in particular tests planned in the protocol) since less of one year.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Memantine | Drug: Memantine<br>* 5 mg the first week, then 10 mg the second week, 15 mg the third week and finally 20 mg the fourth week until the end of the study (t0 + 1 year)<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* 5 mg the first week, then 10 mg the second week, 15 mg the third week and finally 20 mg the fourth week until the end of the study (t0 + 1 year)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pace Auditory Serial Addition Test(P.A.S.A.T) |  | +1 year |