Study on Cognitive Disorders of Multiple Sclerosis

This study has been completed.

Sponsor:

Collaborators:

Ministry of Health, France

H. Lundbeck A/S

Information provided by (Responsible Party):

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT01074619

First received: September 12, 2005

Last updated: August 31, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

August 31, 2012

Start Date ^ICMJE

September 2005

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pace Auditory Serial Addition Test(P.A.S.A.T) [ Time Frame: +1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01074619 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study on Cognitive Disorders of Multiple Sclerosis

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

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)
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)

Study Arm (s)

Experimental: 1
Memantine

Intervention: Drug: Memantine
Placebo Comparator: 2
Placebo

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2011

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01074619

Other Study ID Numbers ^ICMJE

04-087

Has Data Monitoring Committee

Not Provided

Responsible Party

University Hospital, Caen

Study Sponsor ^ICMJE

University Hospital, Caen

Collaborators ^ICMJE

Ministry of Health, France
H. Lundbeck A/S

Investigators ^ICMJE

Principal Investigator:

Defer Gilles, Professor

Centre Hospitalier Universitaire de Caen

Information Provided By

University Hospital, Caen

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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