Study on Cognitive Disorders of Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Memantine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility 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.
Sites / Locations
- CHU Caen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Memantine
Placebo
Outcomes
Primary Outcome Measures
Pace Auditory Serial Addition Test(P.A.S.A.T)
Secondary Outcome Measures
Full Information
NCT ID
NCT01074619
First Posted
September 12, 2005
Last Updated
August 31, 2012
Sponsor
University Hospital, Caen
Collaborators
Ministry of Health, France, H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT01074619
Brief Title
Study on Cognitive Disorders of Multiple Sclerosis
Official Title
Effects of Memantine on Cognitive Disorders of Relapsing-remitting Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Ministry of Health, France, H. Lundbeck A/S
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Memantine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Memantine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Pace Auditory Serial Addition Test(P.A.S.A.T)
Time Frame
+1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Defer Gilles, Professor
Organizational Affiliation
Centre Hospitalier Universitaire de Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14033
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27000224
Citation
Peyro Saint Paul L, Creveuil C, Heinzlef O, De Seze J, Vermersch P, Castelnovo G, Cabre P, Debouverie M, Brochet B, Dupuy B, Lebiez P, Sartori E, Clavelou P, Brassat D, Lebrun-Frenay C, Daplaud D, Pelletier J, Coman I, Hautecoeur P, Tourbah A, Defer G. Efficacy and safety profile of memantine in patients with cognitive impairment in multiple sclerosis: A randomized, placebo-controlled study. J Neurol Sci. 2016 Apr 15;363:69-76. doi: 10.1016/j.jns.2016.02.012. Epub 2016 Feb 6.
Results Reference
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Study on Cognitive Disorders of Multiple Sclerosis
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