A Prospective Study of Spasticity in Individuals With Multiple Sclerosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2012 by Cira Fraser PhD, RN, ACNS-BC, Fraser, Cira, Ph.D., RN, ACNS-BC.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

Cira Fraser PhD, RN, ACNS-BC, Fraser, Cira, Ph.D., RN, ACNS-BC

ClinicalTrials.gov Identifier:

NCT01111435

First received: April 26, 2010

Last updated: March 2, 2012

Last verified: March 2012

History of Changes

Purpose

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
Spasticity


Study Type:	Observational
Study Design:	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®)

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Cira Fraser PhD, RN, ACNS-BC, Fraser, Cira, Ph.D., RN, ACNS-BC:

Primary Outcome Measures:

Multiple Sclerosis Spasticity Scale [ Time Frame: Administered at 6 month follow-up ]

Secondary Outcome Measures:

Performance Scales (Measure of Disability) [ Time Frame: Administered at 6 month follow-up ]


Estimated Enrollment:	110
Study Start Date:	April 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Individuals with Multiple Sclerosis

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Individuals with Multiple Sclerosis living in the community

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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111435

Locations


United States, Missouri
Shared Solutions Call Center
Kansas City, Missouri, United States, 64131

Sponsors and Collaborators

Fraser, Cira, Ph.D., RN, ACNS-BC

Investigators


Principal Investigator:	Cira Fraser, PHD	Monmouth University

More Information

Publications:

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.


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
Study First Received:	April 26, 2010
Last Updated:	March 2, 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

ClinicalTrials.gov processed this record on August 18, 2017

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