Clinical trial NCT01074619: Study on Cognitive Disorders of Multiple Sclerosis
Official title: Effects of Memantine on Cognitive Disorders of Relapsing-remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: H. Lundbeck A/S
First posted: 2010-02-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Pace Auditory Serial Addition Test(P.A.S.A.T)
timeFrame: +1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen
Study officials:
affiliation: Centre Hospitalier Universitaire de Caen
name: Defer Gilles, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peyro Saint Paul L, Creveuil C, Heinzlef O, De Seze J, Vermersch P, Castelnovo G, Cabre P, Debouverie M, Brochet B, Dupuy B, Lebiez P, Sartori E, Clavelou P, Brassat D, Lebrun-Frenay C, Daplaud D, Pelletier J, Coman I, Hautecoeur P, Tourbah A, Defer G. Efficacy and safety profile of memantine in patients with cognitive impairment in multiple sclerosis: A randomized, placebo-controlled study. J Neurol Sci. 2016 Apr 15;363:69-76. doi: 10.1016/j.jns.2016.02.012. Epub 2016 Feb 6.