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Study on Cognitive Disorders of Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01074619
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : September 3, 2012
Sponsor:
Collaborators:
Ministry of Health, France
H. Lundbeck A/S
Information provided by (Responsible Party):
University Hospital, Caen

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Memantine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
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
Study Start Date : September 2005
Actual Primary Completion Date : March 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Memantine
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
Placebo
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)




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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074619


Locations
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France
CHU Caen
Caen, France, 14033
Sponsors and Collaborators
University Hospital, Caen
Ministry of Health, France
H. Lundbeck A/S
Investigators
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Principal Investigator: Defer Gilles, Professor Centre Hospitalier Universitaire de Caen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01074619    
Other Study ID Numbers: 04-087
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
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
Memantine
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