Clinical trial NCT01111435: A Prospective Study of Spasticity in Individuals With Multiple Sclerosis
Official title: A Prospective Study of Spasticity in Individuals With Multiple Sclerosis in Transition From Interferon to Glatiramer Acetate (Copaxone®)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spasticity
Lead sponsor: Fraser, Cira, Ph.D., RN, ACNS-BC
Sponsor class: INDIV
First posted: 2010-04-27
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Multiple Sclerosis living in the community

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.

Eligibility criteria: 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

Primary outcomes:
measure: Multiple Sclerosis Spasticity Scale
timeFrame: Administered at 6 month follow-up
Secondary outcomes:
measure: Performance Scales (Measure of Disability)
timeFrame: Administered at 6 month follow-up
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Shared Solutions Call Center
state: Missouri
Study officials:
affiliation: Monmouth University
name: Cira Fraser, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meca-Lallana, J.E., Amorin-Diaz, M., Martinez-Navarro, M.L. & Fernandez- Barreiro, A. (2008). Spasticity in multiple sclerosis: A pilot study to evaluate the efficacy of glatiramer acetate. Multiple Sclerosis, 145 (Suppl. 2), S165.