A Prospective Study of Spasticity in Individuals With Multiple Sclerosis
1 other identifier
observational
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 26, 2010
CompletedFirst Posted
Study publicly available on registry
April 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 5, 2012
March 1, 2012
2.4 years
April 26, 2010
March 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Multiple Sclerosis Spasticity Scale
Administered at 6 month follow-up
Secondary Outcomes (1)
Performance Scales (Measure of Disability)
Administered at 6 month follow-up
Study Arms (1)
Individuals with Multiple Sclerosis
Eligibility Criteria
Individuals with Multiple Sclerosis living in the community
You may qualify if:
- 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
You may not qualify if:
- Severe Gait Disability or Total Gait Disability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shared Solutions Call Center
Kansas City, Missouri, 64131, United States
Related Publications (1)
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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cira Fraser, PHD
Monmouth University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 26, 2010
First Posted
April 27, 2010
Study Start
April 1, 2010
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
March 5, 2012
Record last verified: 2012-03