Memantine for Spasticity in MS Patients
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: placebo Drug: memantine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Memantine for Spasticity in MS Patients |
- Ashworth Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Memantine 10 mg bid
|
Drug: memantine
10 mg bid
Other Name: Namenda
|
|
Placebo Comparator: 2
Placebo
|
Drug: placebo
matched tablets bid
Other Name: placebo
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations| Contact: Cindy Irish, RN | 585-275-6120 | cindy_irish@urmc.rochester.edu |
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: | Steven R Schwid, MD | University of Rochester |
More Information
No publications provided by University of Rochester
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Steven Schwid, MD, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00638027 History of Changes |
| Other Study ID Numbers: | 8049 |
| Study First Received: | March 10, 2008 |
| Last Updated: | April 10, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Rochester:
|
multiple sclerosis |
Additional relevant MeSH terms:
|
Multiple Sclerosis Muscle Spasticity Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations |
Signs and Symptoms Pathologic Processes Memantine Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013