Memantine for Spasticity in MS Patients

NCT ID: NCT00638027

Last Updated: 2015-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-02-28

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Memantine 10 mg bid

Group Type: EXPERIMENTAL

memantine

Intervention Type: DRUG

10 mg bid

2

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

matched tablets bid

Interventions

placebo

matched tablets bid

Intervention Type: DRUG

memantine

10 mg bid

Intervention Type: DRUG

Other Intervention Names

Namenda

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Andrew Goodman

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew D Goodman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20028712 (View on PubMed)

Other Identifiers

8049

Identifier Type: -

Identifier Source: org_study_id