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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01111435

Enrollment

110

Registered

2010-04-27

Start date

2010-04-30

Completion date

2012-12-31

Last updated

2012-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasticity

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results