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A Prospective Study of Spasticity in Individuals With Multiple Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by 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:

  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.

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:

U.S. FDA Resources

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

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: 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
Genders Eligible for Study:   Both
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
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Muscle Spasticity
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
 Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015