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A Prospective Study of Spasticity in Individuals With Multiple Sclerosis

Sponsor
Fraser, Cira, Ph.D., RN, ACNS-BC (Other)
Overall Status
Unknown status
CT.gov ID
NCT01111435
Collaborator
(none)
110
Enrollment
1
Location
32
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is expected to contribute to the body of knowledge on the benefits of individuals with MS taking glatiramer acetate (Copaxone®). If patients have less spasticity when taking glatiramer acetate (Copaxone®), they may be more likely to have an improved quality of life.

The hypotheses for this study are:

  1. Study participants who transition from interferon therapy to glatiramer acetate (Copaxone®) for a six month period will have a decrease in spasticity.

  2. Study participants who transition from interferon therapy to glatiramer acetate (Copaxone®) for a six month period will have a change in perceptions of the impact of spasticity on their lives.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this study is to determine if there is a change in spasticity and perceptions of the impact of spasticity in individuals with multiple sclerosis who transition from interferon to glatiramer acetate (Copaxone®).•

    • Potential participants meeting the criteria will be identified by Shared Solutions and informed of the study. Interested individuals will contact the investigator either by email or telephone. Enrollment will continue until there are 110 participants starting glatiramer acetate (Copaxone®).

    • Potential participants will be informed of the details of the study, eligibility will be confirmed, and participant's questions answered.

    • The two study instruments and the sociodemographic questionnaire will be emailed or mailed via UPS along with an information letter. May be returned either via email, fax or UPS mail.

    • At month 6 for each participant, the study instruments and sociodemographic questionnaire will be sent a second time and returned to the investigator.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    110 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Study of Spasticity in Individuals With Multiple Sclerosis in Transition From Interferon to Glatiramer Acetate (Copaxone®)
    Study Start Date :
    Apr 1, 2010
    Anticipated Primary Completion Date :
    Sep 1, 2012
    Anticipated Study Completion Date :
    Dec 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Individuals with Multiple Sclerosis

    Outcome Measures

    Primary Outcome Measures

    1. Multiple Sclerosis Spasticity Scale [Administered at 6 month follow-up]

    Secondary Outcome Measures

    1. Performance Scales (Measure of Disability) [Administered at 6 month follow-up]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Stopped interferon (beta-1a or beta-1b) within the past 30 days

    • About to start or started glatiramer acetate (Copaxone®) within the past 21 days.

    • At least 18 years of age

    • Has spasticity at the beginning of the study

    • Able to ambulate with unilateral support or without support

    • Understands, speaks and reads English

    Exclusion Criteria:
    • Severe Gait Disability or Total Gait Disability

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shared Solutions Call Center Kansas City Missouri United States 64131

    Sponsors and Collaborators

    • Fraser, Cira, Ph.D., RN, ACNS-BC

    Investigators

    • Principal Investigator: Cira Fraser, PHD, Monmouth University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Cira Fraser PhD, RN, ACNS-BC, Associate Professor, Fraser, Cira, Ph.D., RN, ACNS-BC
    ClinicalTrials.gov Identifier:
    NCT01111435
    Other Study ID Numbers:
    • Spasticity2010
    First Posted:
    Apr 27, 2010
    Last Update Posted:
    Mar 5, 2012
    Last Verified:
    Mar 1, 2012
    Additional relevant MeSH terms:
    Muscle Spasticity
    Multiple Sclerosis

    Study Results

    No Results Posted as of Mar 5, 2012