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Completed

NCT Number: NCT01074619

Study on Cognitive Disorders of Multiple Sclerosis

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Caen

Caen, 14033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Memantine

Drug

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

Drug

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)

Primary outcomes

  1. Pace Auditory Serial Addition Test(P.A.S.A.T)

    Time frame: +1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • H. Lundbeck A/S
  • Ministry of Health, France

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Feb 24, 2010
Registry last updated
Sep 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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