A Prospective Study of Spasticity in Individuals With Multiple Sclerosis

March 2, 2012 updated by: Cira Fraser PhD, RN, ACNS-BC, Fraser, Cira, Ph.D., RN, ACNS-BC

A Prospective Study of Spasticity in Individuals With Multiple Sclerosis in Transition From Interferon to Glatiramer Acetate (Copaxone®)

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Shared Solutions Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals with Multiple Sclerosis living in the community

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Individuals with Multiple Sclerosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Multiple Sclerosis Spasticity Scale
Time Frame: Administered at 6 month follow-up
Administered at 6 month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Performance Scales (Measure of Disability)
Time Frame: Administered at 6 month follow-up
Administered at 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Cira Fraser, PHD, Monmouth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Meca-Lallana, J.E., Amorin-Diaz, M., Martinez-Navarro, M.L. & Fernandez- Barreiro, A. (2008). Spasticity in multiple sclerosis: A pilot study to evaluate the efficacy of glatiramer acetate. Multiple Sclerosis, 145 (Suppl. 2), S165.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

September 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

April 26, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (ESTIMATE)

April 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2012

Last Update Submitted That Met QC Criteria

March 2, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Spasticity2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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