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Memantine Therapy for Multiple Sclerosis (Memantine-MS)

This study has been terminated.
(Unexpected side-effects: reversible and mild to moderate neurological impairment)
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT00638833
First received: March 12, 2008
Last updated: June 7, 2012
Last verified: June 2012

March 12, 2008
June 7, 2012
September 2007
March 2008   (final data collection date for primary outcome measure)
to assess the efficacy of Memantine in improving memory deficit in MS patients using the SRT scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00638833 on ClinicalTrials.gov Archive Site
1. tests for attention (PASAT3, SDMT, Stroop), executive (Raven, MATTIS) and memory (10/36, SRT), quality of life (SF36), and fatigue (Krupp). 2. attention evoked potentials 3. clinical course, disability (EDSS, MSFC, MSSS). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Memantine Therapy for Multiple Sclerosis
Pilot Clinical Trial With Memantine for Cognitive Deficits in Patients With Multiple Sclerosis

To assess the efficacy of Memantine in improving the cognitive impairment in patients with Multiple Sclerosis (MS)

Memantine is an NMDA receptor antagonist that improves cognitive and behavioural deficits in patients with Alzheimer disease, vascular dementia and mixed dementia. This study is focused in proving the efficacy of Memantine in ameliorating one of the most frequent symptoms of patients with MS which is attention and memory deficits. Memantine is a safe drug in patients with MS and it has been administered to MS patients with pendular nystagmus (Starck et al J Neurol 1997). The study will have the power to detect differences in such clinical question by studying 60 MS patients with cognitive impairment (n=60)) with a crossover design. Indeed, we plan to use a new and powerful surrogate marker such as attention evoked potentials developed in our center. Finally, because there are evidences that Memantine might improve MS outcome by closing the Brain-Blood barrier (which is the best therapeutic target in this disease) (Paul et al J Pharmacol Exp Ther 2002), an exploratory study of its efficacy in preventing new MRI lesions might also be included in the design.

Aims: To assess the efficacy of Memantine in improving the cognitive impairment in patients with Multiple Sclerosis (MS) Primary end-point: to assess the efficacy of Memantine in improving memory deficit in MS patients using the SRT scale

Secondary end-points:

  1. To assess the efficacy of Memantine in improving the performance in the individual neuropsychological tests for attention (PASAT3, SDMT, Stroop), executive (Raven, MATTIS) and memory (10/36, SRT), in the neuropsychological global scale BRB-N Z (Sepulcre et al, submitted) in quality of life (SF36), disability (EDSS, MSFC, MSSS) and fatigue (Krupp).
  2. to assess the effect of Memantine in attention evoked potentials (EP)
  3. to assess the effect of Memantine in clinical course (new relapses, relapse rate, patients free of relapses), disability (EDSS, MSFC, MSSS) and MRI parameters (active lesions: new T2 lesions, change in T2 lesion load, new gadolinium enhancing lesions and global and regional atrophy) in the response to Memantine. MRI study is optional.
  4. to identify the predictors of good or bad response to Memantine therapy by using EP as surrogate markers.

Design: double blind, randomize and crossover clinical trial with Memantine compared with placebo in MS patients. Because Memantine have a hal-life of 2 to 4 days period, at the end of the 6 month, patients we will stay 3 weeks without any therapy (placebo or Memantine) in order to washout Memantine in the therapeutic group

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: Memantine
    Memantine 30 mg/day (20-10-0)
    Other Name: Ebixa
  • Drug: Placebo
    Placebo pills
    Other Name: Placebo
  • Active Comparator: A
    Memantine 30 mg/day
    Intervention: Drug: Memantine
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with MS (McDonald 2002), both sex, age between 18 to 60 years old, all MS subtypes (RR, SP, PP, PR), stable.
  • Patients with severe cognitive impairment defined as performing 1.5 SD below control group (matched by age and education) in 2 o more subtests based in our previous study (Sepulcre 2006):

Exclusion Criteria:

  • Psychiatric diseases (Cummings) depression (Hamilton >8), drug or alcohol abuse, benzodiazepine therapy or other medical diseases.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00638833
11495A
No
Clinica Universidad de Navarra, Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
H. Lundbeck A/S
Principal Investigator: Pablo Villoslada, MD University of Navarra
Clinica Universidad de Navarra, Universidad de Navarra
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP