NCT01111435

A Prospective Study of Spasticity in Individuals With Multiple Sclerosis

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: Fraser, Cira, Ph.D., RN, ACNS-BC · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Spasticity

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2010-04-27
• Last updated: 2012-03-05

Locations

1 site across 1 country: United States