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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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Participants (n=20) will be identified at routine care visits performed at the Rochester Multiple Sclerosis Center. Eligible participants will have MS by McDonald Criteria,7 and will have a modified Ashworth spasticity rating8 of two or higher in at least one lower extremity muscle group. Participants will be seen at screening, one, and three months, and will be evaluated using the modified Ashworth scale,8 pendulum test,9 toe tapping test,10 manual muscle testing,11 timed 25 foot walk,12 and Multiple Sclerosis Functional Composite.13 The type and severity of any adverse events will be recorded using standard definitions. Participants will be instructed to call between visits to inform the investigators regarding any adverse events they experience. Follow-up will continue until all adverse events resolve or stabilize.
This is a randomized, placebo controlled, double-blind, parallel group trial of memantine in patients with MS and spasticity. Participants will be identified at routine care visits at the Rochester Multiple Sclerosis Center. After obtaining informed consent, patients will undergo screening, which will include a physical/neurologic exam and an assessment of the Expanded Disability Status Scale, spasticity, and functional abilities. Eligible patients will return for a baseline evaluation, will initiate their randomly assigned study medication, and will return after one and three months for re-evaluation. The type and severity of any adverse events will be recorded using standard definitions. Participants will be instructed to call between visits to inform the investigators regarding any adverse events they experience. Follow-up will continue until all adverse events resolve or stabilize.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Memantine 10 mg bid |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | matched tablets bid |
| |
| memantine |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Ashworth Spasticity Scale Score Between 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
| Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Multiple Sclerosis Spacticy Scale (MSSS-88) Between Baseline and 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Goodman, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20028712 | Derived | Mehta LR, McDermott MP, Goodman AD, Schwid SR. A randomized trial of memantine as treatment for spasticity in multiple sclerosis. Mult Scler. 2010 Feb;16(2):248-51. doi: 10.1177/1352458509355462. Epub 2009 Dec 22. |
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Recruitment for the trial began in June 2006 and ended in June 2008. The last subject formally completed the trial in September 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Memantine | Memantine 10 mg bid |
| FG001 | Placebo | Placebo arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Memantine | Memantine 10 mg bid |
| BG001 | Placebo | Placebo arm |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Ashworth Spasticity Scale Score Between 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
| Per Protocol | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Memantine | Memantine 10 mg bid |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Small exploratory study that may have been hindered due to lack of adequate power.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Irish, RN, MSCN | University of Rochester | 585-275-6120 | cindy_irish@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
10 mg bid |
|
|
| baseline, 12 weeks |
| Change in Multiple Sclerosis Functional Composite (MSFC) Score Between Baseline and 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. | Baseline, Week 12 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Placebo arm |
|
|
| Secondary | Difference in the Multiple Sclerosis Spacticy Scale (MSSS-88) Between Baseline and 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. | per protocol | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 weeks |
|
|
|
| Secondary | Change in Multiple Sclerosis Functional Composite (MSFC) Score Between Baseline and 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. | Per protocol | Posted | Mean | Standard Deviation | Z score | Baseline, Week 12 |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Placebo | Placebo arm | 0 | 10 | 5 | 10 |
| urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| left ankle sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| nausea | General disorders | Non-systematic Assessment |
|
| influenza | Infections and infestations | Non-systematic Assessment |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |