Memantine Therapy for Multiple Sclerosis (Memantine-MS)
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Purpose
To assess the efficacy of Memantine in improving the cognitive impairment in patients with Multiple Sclerosis (MS)
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Memantine Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Pilot Clinical Trial With Memantine for Cognitive Deficits in Patients With Multiple Sclerosis |
- 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 ]
- 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 ]
| Enrollment: | 20 |
| Study Start Date: | September 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Memantine 30 mg/day
|
Drug: Memantine
Memantine 30 mg/day (20-10-0)
Other Name: Ebixa
|
|
Placebo Comparator: B
Placebo
|
Drug: Placebo
Placebo pills
Other Name: Placebo
|
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:
- 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).
- to assess the effect of Memantine in attention evoked potentials (EP)
- 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.
- 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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Spain | |
| Clinica Universitaria de Navarra | |
| Pamplona, Navarra, Spain, 31008 | |
| Principal Investigator: | Pablo Villoslada, MD | University of Navarra |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Clinica Universidad de Navarra, Universidad de Navarra |
| ClinicalTrials.gov Identifier: | NCT00638833 History of Changes |
| Other Study ID Numbers: | 11495A |
| Study First Received: | March 12, 2008 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
|
Multiple Sclerosis |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Memantine Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013