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Cognitive Effects of Immunomodulatory Drugs in MS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00229502
First Posted: September 29, 2005
Last Update Posted: March 23, 2012
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.
Collaborator:
EMD Serono
Information provided by (Responsible Party):
Sharon Lynch, MD, University of Kansas Medical Center Research Institute
  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 Sharon Lynch, MD, University of Kansas Medical Center Research Institute:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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 Medical Center
Principal Investigator: Douglas R Denney, PhD University of Kansas Medical Center
  More Information

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
First Submitted: September 27, 2005
First Posted: September 29, 2005
Last Update Posted: March 23, 2012
Last Verified: March 2012

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


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