A Prospective Study of Spasticity in Individuals With Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT01111435 |
Recruitment Status
: Unknown
Verified March 2012 by Cira Fraser PhD, RN, ACNS-BC, Fraser, Cira, Ph.D., RN, ACNS-BC.
Recruitment status was: Active, not recruiting
First Posted
: April 27, 2010
Last Update Posted
: March 5, 2012
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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.
Condition or disease |
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Spasticity |
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.
Study Type : | Observational |
Estimated Enrollment : | 110 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prospective Study of Spasticity in Individuals With Multiple Sclerosis in Transition From Interferon to Glatiramer Acetate (Copaxone®) |
Study Start Date : | April 2010 |
Estimated Primary Completion Date : | September 2012 |
Estimated Study Completion Date : | December 2012 |

Group/Cohort |
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Individuals with Multiple Sclerosis |
- Multiple Sclerosis Spasticity Scale [ Time Frame: Administered at 6 month follow-up ]
- Performance Scales (Measure of Disability) [ Time Frame: Administered at 6 month follow-up ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111435
United States, Missouri | |
Shared Solutions Call Center | |
Kansas City, Missouri, United States, 64131 |
Principal Investigator: | Cira Fraser, PHD | Monmouth University |
Publications:
Responsible Party: | Cira Fraser PhD, RN, ACNS-BC, Associate Professor, Fraser, Cira, Ph.D., RN, ACNS-BC |
ClinicalTrials.gov Identifier: | NCT01111435 History of Changes |
Other Study ID Numbers: |
Spasticity2010 |
First Posted: | April 27, 2010 Key Record Dates |
Last Update Posted: | March 5, 2012 |
Last Verified: | March 2012 |
Additional relevant MeSH terms:
Muscle Spasticity Sclerosis Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations Signs and Symptoms |