Memantine for Spasticity in MS Patients
Memantine for Spasticity in MS Patients
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Memantine
Placebo
- placebo
Results by group
Difference in Ashworth Spasticity Scale Score Between Baseline and 12 Weeks
Baseline and 12 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Memantine | -1.55 units on a scale | 2.81 (Standard Deviation) | 11 |
| Placebo | -1.00 units on a scale | 2.67 (Standard Deviation) | 10 |
Memantine
Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Memantine | 11 | 0 (0.0%) | |
| Placebo | 10 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Difference in Ashworth Spasticity Scale Score Between Baseline and 12 Weeks
Baseline and 12 weeks
Spasticity
Other measures (2)
Difference in the Multiple Sclerosis Spacticy Scale (MSSS-88) Between Baseline and 12 Weeks
baseline, 12 weeks
SpasticityQuality of life (reported by participants)Change in Multiple Sclerosis Functional Composite (MSFC) Score Between Baseline and Week 12
Baseline, Week 12
Disability progressionThinking and memoryWalking and mobilityArm and hand function
Who could take part
MS (type not specified) · 18 to 70
Show the full criteria
Inclusion criteria
1. Multiple sclerosis by McDonald Criteria. 2. Spasticity. A minimum score of two on the Ashworth spasticity scale in at least one lower extremity muscle group and a total score of at least four in the lower extremity muscles tested. 3. Age 18-70. 4. Normal renal function (estimated CrCl > 50 ml/min). 5. Women of childbearing potential (i.e., those not postmenopausal or surgically sterile) may participate provided that they are using adequate birth control methods (including barrier methods, IUD, and oral contraceptives) for the duration of the study. 6. Willing and able to perform all procedures related to the clinical trial and to provide informed consent.
Exclusion criteria
1. Evidence of clinically significant thyroid, gastrointestinal, cardiovascular, hepatic, renal, hematologic, respiratory, neoplastic, endocrine (including diabetes mellitus), neurologic (other than MS), or other medical or psychiatric disorder at screening. 2. Women must not be pregnant or lactating. Serum or urine pregnancy tests will be required prior to randomization for women of childbearing potential unless the last menstrual period started less than 28 days prior to randomization.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Jul 2006
Main results due
Feb 2009
Finished
Feb 2009
Results posted
Dec 2015