Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Delirium, Dementia, Amnestic, Cognitive Disorders
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Mental Disorders
Nervous System Diseases
Pathologic Processes
Memantine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014