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Study on Cognitive Disorders of Multiple Sclerosis

This study has been completed.
Ministry of Health, France
H. Lundbeck A/S
Information provided by (Responsible Party):
University Hospital, Caen Identifier:
First received: September 12, 2005
Last updated: August 31, 2012
Last verified: August 2012
The purpose of this study is to determine if memantine is effective in the treatment on cognitive disorders of Relapsing - Remitting multiple sclerosis. m

Condition Intervention Phase
Multiple Sclerosis Drug: Memantine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Memantine on Cognitive Disorders of Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Pace Auditory Serial Addition Test(P.A.S.A.T) [ Time Frame: +1 year ]

Enrollment: 90
Study Start Date: September 2005
Study Completion Date: November 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: 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 Comparator: 2
Drug: 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)


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01074619

CHU Caen
Caen, France, 14033
Sponsors and Collaborators
University Hospital, Caen
Ministry of Health, France
H. Lundbeck A/S
Principal Investigator: Defer Gilles, Professor Centre Hospitalier universitaire de Caen
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Caen Identifier: NCT01074619     History of Changes
Other Study ID Numbers: 04-087
Study First Received: September 12, 2005
Last Updated: August 31, 2012

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Cognition Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurocognitive Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents processed this record on September 21, 2017