Study on Cognitive Disorders of Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074619
• Other study ID #: 04-087
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: August 31, 2012
• Start date: September 2005
• Est. completion date: November 2011

Study information

• Verified date: August 2012
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cognition Disorders
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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
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)

Locations

Country	Name	City	State
France	CHU Caen	Caen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Caen	H. Lundbeck A/S, Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pace Auditory Serial Addition Test(P.A.S.A.T)		+1 year	No