Clinical trial NCT00638027: Memantine for Spasticity in MS Patients
Official title: Memantine for Spasticity in MS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2008-03-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Difference in Ashworth Spasticity Scale Score Between Baseline and 12 Weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Difference in the Multiple Sclerosis Spacticy Scale (MSSS-88) Between Baseline and 12 Weeks
timeFrame: baseline, 12 weeks
measure: Change in Multiple Sclerosis Functional Composite (MSFC) Score Between Baseline and Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Andrew D Goodman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.