Cognitive Effects of Immunomodulatory Drugs in MS

March 21, 2012 updated by: Sharon Lynch, MD

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

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).

Study Overview

Status

Completed

Conditions

Multiple Sclerosis

Detailed 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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Kansas
  - Kansas City, Kansas, United States, 66160
    - University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Multiple sclerosis clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
4 Healthy controls
1 Subjects receiving Avonex
2 Subjects receiving Rebif
3 Subjects receiving Copaxone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sharon Lynch, MD

Collaborators

EMD Serono

Investigators

Principal Investigator: Sharon G Lynch, MD, University of Kansas Medical Center
Principal Investigator: Douglas R Denney, PhD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria