A Prospective Study of Spasticity in Individuals With Multiple Sclerosis

Spasticity Clinical Trial

Official title:

A Prospective Study of Spasticity in Individuals With Multiple Sclerosis in Transition From Interferon to Glatiramer Acetate (Copaxone®)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01111435
• Other study ID #: Spasticity2010
• Status: Active, not recruiting
• Phase: N/A
• First received: April 26, 2010
• Last updated: March 2, 2012
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: Fraser, Cira, Ph.D., RN, ACNS-BC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Spasticity
• Spasticity

Locations

Country	Name	City	State
United States	Shared Solutions Call Center	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Fraser, Cira, Ph.D., RN, ACNS-BC

Country where clinical trial is conducted

United States, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiple Sclerosis Spasticity Scale		Administered at 6 month follow-up	No
Secondary	Performance Scales (Measure of Disability)		Administered at 6 month follow-up	No