Memantine Therapy for Multiple Sclerosis
Information source: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: Memantine (Drug); Placebo (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Clinica Universidad de Navarra, Universidad de Navarra Official(s) and/or principal investigator(s): Pablo Villoslada, MD, Principal Investigator, Affiliation: University of Navarra
Summary
To assess the efficacy of Memantine in improving the cognitive impairment in patients with
Multiple Sclerosis (MS)
Clinical Details
Official title: Pilot Clinical Trial With Memantine for Cognitive Deficits in Patients With Multiple Sclerosis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: to assess the efficacy of Memantine in improving memory deficit in MS patients using the SRT scale
Secondary outcome: 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).
Detailed description:
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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Clinica Universitaria de Navarra, Pamplona, Navarra 31008, Spain
Additional Information
web page of the medical center of the University of Navarra
Related publications: Sepulcre J, Vanotti S, Hernández R, Sandoval G, Cáceres F, Garcea O, Villoslada P. Cognitive impairment in patients with multiple sclerosis using the Brief Repeatable Battery-Neuropsychology test. Mult Scler. 2006 Apr;12(2):187-95.
Starting date: September 2007
Last updated: June 7, 2012
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