ClinicalTrials.gov
ClinicalTrials.gov Menu

A Prospective Study of Spasticity in Individuals With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):
Cira Fraser PhD, RN, ACNS-BC, Fraser, Cira, Ph.D., RN, ACNS-BC

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Spasticity

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Individuals with Multiple Sclerosis


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Multiple Sclerosis Spasticity Scale [ Time Frame: Administered at 6 month follow-up ]

Secondary Outcome Measures :
  1. Performance Scales (Measure of Disability) [ Time Frame: Administered at 6 month follow-up ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Older Adult)
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
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