Cognitive Effects of Immunomodulatory Drugs in MS

This study has been completed.
Sponsor:
Collaborator:
EMD Serono
Information provided by (Responsible Party):
Sharon Lynch, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00229502
First received: September 27, 2005
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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).


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of the Cognitive Effects of Three Immunomodulatory Drugs in Relapsing-Remitting Multiple Sclerosis: A Longitudinal Study

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Enrollment: 96
Study Start Date: September 2005
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subjects receiving Avonex
2
Subjects receiving Rebif
3
Subjects receiving Copaxone
4
Healthy controls

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Multiple sclerosis clinic

Criteria

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
  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: NCT00229502

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Sharon Lynch, MD
EMD Serono
Investigators
Principal Investigator: Sharon G Lynch, MD University of Kansas
Principal Investigator: Douglas R Denney, PhD University of Kansas
  More Information

No publications provided

Responsible Party: Sharon Lynch, MD, Professor and Director of MS Center, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00229502     History of Changes
Other Study ID Numbers: 10066
Study First Received: September 27, 2005
Last Updated: March 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014