Memantine for Spasticity in MS Patients

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.

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.