Memantine for Spasticity in MS Patients
Information source: University of Rochester
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: placebo (Drug); memantine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Rochester Official(s) and/or principal investigator(s): Steven R Schwid, MD, Principal Investigator, Affiliation: University of Rochester
Overall contact: Cindy Irish, RN, Phone: 585-275-6120, Email: cindy_irish@urmc.rochester.edu
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.
Clinical Details
Official title: Memantine for Spasticity in MS Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Ashworth Scale
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Cindy Irish, RN, Phone: 585-275-6120, Email: cindy_irish@urmc.rochester.edu
University of Rochester, Rochester, New York 14642, United States; Recruiting
Additional Information
Starting date: July 2006
Last updated: April 10, 2009
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