A Prospective Study of Spasticity in Individuals With Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spasticity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Individuals with Multiple Sclerosis

No interventions assigned to this group

Eligibility Criteria

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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