Study on Cognitive Disorders of Multiple Sclerosis
Effects of Memantine on Cognitive Disorders of Relapsing-remitting Multiple Sclerosis
What it found
The main measure did not show a significant benefit.
“After adjusting for the PASAT scores at baseline, the PASAT scores at the end point did not differ between the memantine and the placebo groups (p=0.88).”Read by software from the paper's abstract
Paced Auditory Serial Addition Test (PASAT) score at week 52 · 52 weeks
adjusted mean score difference (memantine minus placebo) -0.40 (95% CI -5.5–+4.7)
p = 0.88
Read by software from the paper's abstract
What was tested
Treatment tested
- Memantine
Placebo
- Placebo
What it measured
Main measures
Pace Auditory Serial Addition Test(P.A.S.A.T)
+1 year
Who could take part
Relapsing MS · 18 to 60
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to determine if memantine is effective in the treatment on cognitive disorders of Relapsing - Remitting multiple sclerosis. m
Papers
Results
Efficacy and safety profile of memantine in patients with cognitive impairment in multiple sclerosis: A randomized, placebo-controlled study.J Neurol Sci · 2016
After adjusting for the PASAT scores at baseline, the PASAT scores at the end point did not differ between the memantine and the placebo groups (p=0.88).
Read by software from the paper's abstract
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History
Started
Sept 2005
Main results due
Mar 2011
Finished
Nov 2011