Study Stopped
Unexpected side-effects: reversible and mild to moderate neurological impairment
Memantine Therapy for Multiple Sclerosis
Memantine-MS
Pilot Clinical Trial With Memantine for Cognitive Deficits in Patients With Multiple Sclerosis
1 other identifier
interventional
20
1 country
1
Brief Summary
To assess the efficacy of Memantine in improving the cognitive impairment in patients with Multiple Sclerosis (MS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 multiple-sclerosis
Started Sep 2007
Shorter than P25 for phase_2 multiple-sclerosis
1 active site
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, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 12, 2008
CompletedFirst Posted
Study publicly available on registry
March 19, 2008
CompletedJune 8, 2012
June 1, 2012
6 months
March 12, 2008
June 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to assess the efficacy of Memantine in improving memory deficit in MS patients using the SRT scale
6 months
Secondary Outcomes (1)
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).
6 months
Study Arms (2)
A
ACTIVE COMPARATORMemantine 30 mg/day
B
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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):
You may not qualify if:
- Psychiatric diseases (Cummings) depression (Hamilton \>8), drug or alcohol abuse, benzodiazepine therapy or other medical diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Related Publications (2)
Sepulcre J, Vanotti S, Hernandez R, Sandoval G, Caceres 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. doi: 10.1191/1352458506ms1258oa.
PMID: 16629422BACKGROUNDVilloslada P, Arrondo G, Sepulcre J, Alegre M, Artieda J. Memantine induces reversible neurologic impairment in patients with MS. Neurology. 2009 May 12;72(19):1630-3. doi: 10.1212/01.wnl.0000342388.73185.80. Epub 2008 Dec 17.
PMID: 19092106DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pablo Villoslada, MD
University of Navarra
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2008
First Posted
March 19, 2008
Study Start
September 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
June 8, 2012
Record last verified: 2012-06