Status:
COMPLETED
Memantine for Spasticity in MS Patients
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Forest Laboratories
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 A...
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 Mu...
Eligibility Criteria
Inclusion
- Multiple sclerosis by McDonald Criteria.
- 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.
- Age 18-70.
- Normal renal function (estimated CrCl \> 50 ml/min).
- 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.
- Willing and able to perform all procedures related to the clinical trial and to provide informed consent.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00638027
Start Date
July 1 2006
End Date
February 1 2009
Last Update
December 7 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Rochester
Rochester, New York, United States, 14642