Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
2005-09-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Memantine
Memantine
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)
2
Placebo
Placebo
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)
Interventions
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Memantine
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)
Placebo
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
H. Lundbeck A/S
INDUSTRY
University Hospital, Caen
OTHER
Responsible Party
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Principal Investigators
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Defer Gilles, Professor
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Caen
Locations
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CHU Caen
Caen, , France
Countries
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References
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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.
Other Identifiers
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04-087
Identifier Type: -
Identifier Source: org_study_id