Study on Cognitive Disorders of Multiple Sclerosis
This study has been completed.
Sponsor:
University Hospital, Caen
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
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Purpose
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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Memantine on Cognitive Disorders of Relapsing-remitting Multiple Sclerosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]
| 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
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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074619
Locations
| France | |
| CHU Caen | |
| Caen, France, 14033 | |
Sponsors and Collaborators
University Hospital, Caen
Ministry of Health, France
H. Lundbeck A/S
Investigators
| Principal Investigator: | Defer Gilles, Professor | Centre Hospitalier Universitaire de Caen |
More Information
No publications provided
| Responsible Party: | University Hospital, Caen |
| ClinicalTrials.gov Identifier: | NCT01074619 History of Changes |
| Other Study ID Numbers: | 04-087 |
| Study First Received: | September 12, 2005 |
| Last Updated: | August 31, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Cognition Disorders Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
Memantine Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013