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NCT00229502 Clinical Trial

Cognitive Effects of Immunomodulatory Drugs in MS

Multiple Sclerosis Clinical Trial

Official title:
Comparison of the Cognitive Effects of Three Immunomodulatory Drugs in Relapsing-Remitting Multiple Sclerosis: A Longitudinal Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00229502
Other study ID # 10066
Secondary ID
Status Completed
Phase N/A
First received September 27, 2005
Last updated March 21, 2012
Start date September 2005
Est. completion date December 2011

Study information
Verified date March 2012
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The purpose of this study is to examine and compare changes in the specific thinking skills of patients with RRMS who are receiving treatment with one of three immunomodulatory medications (Avonex, Copaxone, or Rebif).

Description:

In addition this study will compare the patients' personal view of how they are doing, any changes in physical disability, and the frequency and severity of relapses over the three year period.

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date December 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Diagnosis of RRMS for at least one year,

- Currently on one of three immunomodulatory drugs (Avonex, Copaxone, or Rebif),

- Visual Acuity is 20/50 or better,

- patient has four color vision,

- Must have at least a high school education

Exclusion Criteria:

- History of head injury, drug/alcohol abuse, and/or psychiatric problems, -current diagnosis of a severe or lifethreatening disease other than MS,

- currently taking immunosuppressant medication,

- resides greater than 200 miles from the study site

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (2)
Lead Sponsor Collaborator
Sharon Lynch, MD EMD Serono

Country where clinical trial is conducted

United States, 

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