A Prospective Study of Spasticity in Individuals With Multiple Sclerosis

• Conditions: Spasticity

• Registration Number: NCT01111435
• Lead Sponsor: Fraser, Cira, Ph.D., RN, ACNS-BC

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.

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-02
• Last Update Posted: 2012-03-05
• Primary Completion: 2012-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multiple Sclerosis Spasticity Scale	Administered at 6 month follow-up

Secondary Outcome Measures

Name	Time	Method
Performance Scales (Measure of Disability)	Administered at 6 month follow-up

Trial Locations

Locations (1)

Shared Solutions Call Center; 🇺🇸 Kansas City, Missouri, United States