A Prospective Study of Spasticity in Individuals With Multiple Sclerosis
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:
- Study participants who transition from interferon therapy to glatiramer acetate (Copaxone®) for a six month period will have a decrease in spasticity.
- 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 Design:||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®)|
- Multiple Sclerosis Spasticity Scale [ Time Frame: Administered at 6 month follow-up ] [ Designated as safety issue: No ]
- Performance Scales (Measure of Disability) [ Time Frame: Administered at 6 month follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|Individuals with Multiple Sclerosis|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111435
|United States, Missouri|
|Shared Solutions Call Center|
|Kansas City, Missouri, United States, 64131|
|Principal Investigator:||Cira Fraser, PHD||Monmouth University|