NCT00229502

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 23, 2012

Status Verified

March 1, 2012

Enrollment Period

6 years

First QC Date

September 27, 2005

Last Update Submit

March 21, 2012

Conditions

Multiple Sclerosis

Study Arms (4)

1

Subjects receiving Avonex

2

Subjects receiving Rebif

3

Subjects receiving Copaxone

4

Healthy controls

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Multiple sclerosis clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sharon G Lynch, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

  • Douglas R Denney, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Director of MS Center

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

September 1, 2005

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

March 23, 2012

Record last verified: 2012-03

Locations

US(1)