Memantine for Spasticity in MS Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Memantine for Spasticity in MS Patients|
- Difference in Ashworth Spasticity Scale Score Between Baseline and 12 Weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
spasticity scale score: the most common used tool to measure the degree of spasticity of the lower extremities.
Score: Degree of Muscle Tone 0: no increase in tone
- slight increase in tone 1+: slight increase in tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion.
- more marked increase in muscle tone through most of the range of movement, but affected part(s) easily moved.
- considerable increase in muscle tone, passive movement difficult.
- affected part(s) rigid in flexion or extension.
- Difference in the Multiple Sclerosis Spacticy Scale (MSSS-88) Between Baseline and 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
Multiple Sclerosis Spacticy Scale (MSSS-88) is a patient reported questionnaire rating scale to quantify the perspectives of the impact of spasticity on people with multiple sclerosis.
Scoring: Individual items are scored on a 4 point Likert scale: 1 (Not bothered at all), 2 (a little bothered), 3 (moderately bothered), 4 (extremely bothered).This questionnaire asks how bothered you have been by your spasticity in the past two weeks. By spasticity we mean muscle stiffness and spasms.The MSSS-88 is a reliable and valid, patient-based, interval-level measure of the impact of spasticity in multiple sclerosis. Scores were summed, without weighting or standardization, to generate ordinal-level total scores just as any other Likert-type scale. Missing responses to items can be replaced with the mean score of the items completed (person-specific item mean score) provided that 50% or more of the items in a scale have been completed. The range is 8-32 and higher scores mean poorer outcome.
- Change in Multiple Sclerosis Functional Composite (MSFC) Score Between Baseline and Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
9-Hole Peg Test (9-HPT) is a quantitative measure of upper extremity function. Timed 25-Foot Walk (T 25 FW) is a quantitative measure of lower extremity function. The patient is instructed to walk 25 feet as quickly as possible, but safely.
Paced Auditory Serial Addition Test-3 seconds (PASAT-3) is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.
The MSFC is based on the concept that scores for these 3 dimensions—arm, leg, and cognitive function are combined to create a single score that can be used to detect change over time in a group of MS patients. This is done by creating Z-scores for each component of the MSFC. Implicit in this approach is the idea that patients who deteriorate or improve on all 3 component measures will have an overall larger change than patients who change on only 1 of the 3 measures. The MSFC score was transformed to z-scores, with higher scores indicating better outcome.
|Study Start Date:||July 2006|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Memantine 10 mg bid
10 mg bid
Other Name: Namenda
Placebo Comparator: 2
matched tablets bid
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638027
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Andrew D Goodman, MD||University of Rochester|