Memantine for Spasticity in MS Patients
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|ClinicalTrials.gov Identifier: NCT00638027|
Recruitment Status : Completed
First Posted : March 18, 2008
Results First Posted : December 7, 2015
Last Update Posted : December 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: placebo Drug: memantine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Memantine for Spasticity in MS Patients|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
Memantine 10 mg bid
10 mg bid
Other Name: Namenda
Placebo Comparator: 2
matched tablets bid
- Difference in Ashworth Spasticity Scale Score Between Baseline and 12 Weeks [ Time Frame: Baseline and 12 weeks ]
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 ]
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 ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638027
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Andrew D Goodman, MD||University of Rochester|