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Completed

NCT Number: NCT00638027

Memantine for Spasticity in MS Patients

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

matched tablets bid

Memantine

Drug

10 mg bid

Other names: Namenda

Primary outcomes

  1. Difference in Ashworth Spasticity Scale Score Between Baseline and 12 Weeks

    Time frame: 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

    • 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.
    • more marked increase in muscle tone through most of the range of movement, but affected part(s) easily moved.
    • considerable increase in muscle tone, passive movement difficult.
    • affected part(s) rigid in flexion or extension.

Secondary outcomes

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

    Time frame: baseline, 12 weeks

    Multiple Sclerosis Spacticy Scale (MSSS-88) is a patient reported questionnaire rating scale to quantify the perspectives of the impact of spasticity on people with multiple sclerosis.

    Scoring: Individual items are scored on a 4 point Likert scale: 1 (Not bothered at all), 2 (a little bothered), 3 (moderately bothered), 4 (extremely bothered).This questionnaire asks how bothered you have been by your spasticity in the past two weeks. By spasticity we mean muscle stiffness and spasms.The MSSS-88 is a reliable and valid, patient-based, interval-level measure of the impact of spasticity in multiple sclerosis. Scores were summed, without weighting or standardization, to generate ordinal-level total scores just as any other Likert-type scale. Missing responses to items can be replaced with the mean score of the items completed (person-specific item mean score) provided that 50% or more of the items in a scale have been completed. The range is 8-32 and higher scores mean poorer outcome.

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

    Time frame: Baseline, Week 12

    9-Hole Peg Test (9-HPT) is a quantitative measure of upper extremity function. Timed 25-Foot Walk (T 25 FW) is a quantitative measure of lower extremity function. The patient is instructed to walk 25 feet as quickly as possible, but safely.

    Paced Auditory Serial Addition Test-3 seconds (PASAT-3) is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.

    The MSFC is based on the concept that scores for these 3 dimensions-arm, leg, and cognitive function are combined to create a single score that can be used to detect change over time in a group of MS patients. This is done by creating Z-scores for each component of the MSFC. Implicit in this approach is the idea that patients who deteriorate or improve on all 3 component measures will have an overall larger change than patients who change on only 1 of the 3 measures. The MSFC score was transformed to z-scores, with higher scores indicating better outcome.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Forest Laboratories

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Mar 18, 2008
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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