Overview

This trial is active, not recruiting.

Condition spasticity
Sponsor Fraser, Cira, Ph.D., RN, ACNS-BC
Start date April 2010
End date September 2012
Trial size 110 participants
Trial identifier NCT01111435, Spasticity2010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Multiple Sclerosis Spasticity Scale
time frame: Administered at 6 month follow-up

Secondary Outcomes

Measure
Performance Scales (Measure of Disability)
time frame: Administered at 6 month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective Study of Spasticity in Individuals With Multiple Sclerosis in Transition From Interferon to Glatiramer Acetate (Copaxone®)
Principal investigator Cira Fraser, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Fraser, Cira, Ph.D., RN, ACNS-BC.