Study on Cognitive Disorders of Multiple Sclerosis

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Caen
• Collaborators: H. Lundbeck A/S; Ministry of Health, France
• Treatments: Memantine

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.