A Prospective Study of Spasticity in Individuals With Multiple Sclerosis
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Cira Fraser PhD, RN, ACNS-BC, Fraser, Cira, Ph.D., RN, ACNS-BC
First received: April 26, 2010
Last updated: March 2, 2012
Last verified: March 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||A Prospective Study of Spasticity in Individuals With Multiple Sclerosis in Transition From Interferon to Glatiramer Acetate (Copaxone®)
Primary Outcome Measures:
- Multiple Sclerosis Spasticity Scale [ Time Frame: Administered at 6 month follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Performance Scales (Measure of Disability) [ Time Frame: Administered at 6 month follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Individuals with Multiple Sclerosis living in the community
- 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
- Severe Gait Disability or Total Gait Disability
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111435
|Shared Solutions Call Center
|Kansas City, Missouri, United States, 64131 |
Fraser, Cira, Ph.D., RN, ACNS-BC
||Cira Fraser, PHD
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.
||Cira Fraser PhD, RN, ACNS-BC, Associate Professor, Fraser, Cira, Ph.D., RN, ACNS-BC
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 26, 2010
||March 2, 2012
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 08, 2013
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases
Signs and Symptoms