NCT01074619

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for phase_3 multiple-sclerosis

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_3 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

5.5 years

First QC Date

September 12, 2005

Last Update Submit

August 31, 2012

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Pace Auditory Serial Addition Test(P.A.S.A.T)

    +1 year

Study Arms (2)

1

EXPERIMENTAL

Memantine

Drug: Memantine

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

MemantineDRUG

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)

1
PlaceboDRUG

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)

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Caen

Caen, 14033, France

Location

Related Publications (1)

  • 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.

    PMID: 27000224DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Memantine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Defer Gilles, Professor

    Centre Hospitalier Universitaire de Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

February 24, 2010

Study Start

September 1, 2005

Primary Completion

March 1, 2011

Study Completion

November 1, 2011

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

FR(1)