Memantine for Spasticity in MS Patients

NCT00638027 | Completed Phase 4 Results

• 1 other identifier: 8049
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Difference in Ashworth Spasticity Scale Score Between Baseline and 12 Weeks

  spasticity scale score: the most common used tool to measure the degree of spasticity of the lower extremities. Score: Degree of Muscle Tone 0: no increase in tone 1. slight increase in tone 1+: slight increase in tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion. 2. more marked increase in muscle tone through most of the range of movement, but affected part(s) easily moved. 3. considerable increase in muscle tone, passive movement difficult. 4. affected part(s) rigid in flexion or extension.

  Baseline and 12 weeks

Secondary Outcomes (2)

• Difference in the Multiple Sclerosis Spacticy Scale (MSSS-88) Between Baseline and 12 Weeks

  baseline, 12 weeks

• Change in Multiple Sclerosis Functional Composite (MSFC) Score Between Baseline and Week 12

  Baseline, Week 12

Study Arms (2)

1

EXPERIMENTAL

Memantine 10 mg bid

Drug: memantine

2

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

placebo DRUG

matched tablets bid

2

memantine DRUG

10 mg bid

Also known as: Namenda

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Forest Laboratories: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

• 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.

  PMID: 20028712 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Memantine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Small exploratory study that may have been hindered due to lack of adequate power.

Results Point of Contact

• Title: Cynthia Irish, RN, MSCN
• Organization: University of Rochester

cindy_irish@urmc.rochester.edu

585-275-6120

Study Officials

• Andrew D Goodman, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 18, 2008
• Study Start: July 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 7, 2015
• Results First Posted: December 7, 2015

Record last verified: 2015-11

Locations

US (1)