Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00229502
Status:
COMPLETED
Last Update Posted:
2012-03-23
First Post:
2005-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Effects of Immunomodulatory Drugs in MS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-21', 'studyFirstSubmitDate': '2005-09-27', 'studyFirstSubmitQcDate': '2005-09-27', 'lastUpdatePostDateStruct': {'date': '2012-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Multiple sclerosis clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of RRMS for at least one year,\n* Currently on one of three immunomodulatory drugs (Avonex, Copaxone, or Rebif),\n* Visual Acuity is 20/50 or better,\n* patient has four color vision,\n* Must have at least a high school education\n\nExclusion Criteria:\n\n* History of head injury, drug/alcohol abuse, and/or psychiatric problems, -current diagnosis of a severe or lifethreatening disease other than MS,\n* currently taking immunosuppressant medication,\n* resides greater than 200 miles from the study site'}, 'identificationModule': {'nctId': 'NCT00229502', 'briefTitle': 'Cognitive Effects of Immunomodulatory Drugs in MS', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Comparison of the Cognitive Effects of Three Immunomodulatory Drugs in Relapsing-Remitting Multiple Sclerosis: A Longitudinal Study', 'orgStudyIdInfo': {'id': '10066'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Subjects receiving Avonex'}, {'label': '2', 'description': 'Subjects receiving Rebif'}, {'label': '3', 'description': 'Subjects receiving Copaxone'}, {'label': '4', 'description': 'Healthy controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Sharon G Lynch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}, {'name': 'Douglas R Denney, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sharon Lynch, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'EMD Serono', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor and Director of MS Center', 'investigatorFullName': 'Sharon Lynch, MD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}