Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT01111435
Status:
UNKNOWN
Last Update Posted:
2012-03-05
First Post:
2010-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Study of Spasticity in Individuals With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-02', 'studyFirstSubmitDate': '2010-04-26', 'studyFirstSubmitQcDate': '2010-04-26', 'lastUpdatePostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multiple Sclerosis Spasticity Scale', 'timeFrame': 'Administered at 6 month follow-up'}], 'secondaryOutcomes': [{'measure': 'Performance Scales (Measure of Disability)', 'timeFrame': 'Administered at 6 month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spasticity']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Meca-Lallana, J.E., Amorin-Diaz, M., Martinez-Navarro, M.L. & Fernandez- Barreiro, A. (2008). Spasticity in multiple sclerosis: A pilot study to evaluate the efficacy of glatiramer acetate. Multiple Sclerosis, 145 (Suppl. 2), S165.'}]}, 'descriptionModule': {'briefSummary': 'This study is expected to contribute to the body of knowledge on the benefits of individuals with MS taking glatiramer acetate (Copaxone®). If patients have less spasticity when taking glatiramer acetate (Copaxone®), they may be more likely to have an improved quality of life.\n\nThe hypotheses for this study are:\n\n1. Study participants who transition from interferon therapy to glatiramer acetate (Copaxone®) for a six month period will have a decrease in spasticity.\n2. Study participants who transition from interferon therapy to glatiramer acetate (Copaxone®) for a six month period will have a change in perceptions of the impact of spasticity on their lives.', 'detailedDescription': "The purpose of this study is to determine if there is a change in spasticity and perceptions of the impact of spasticity in individuals with multiple sclerosis who transition from interferon to glatiramer acetate (Copaxone®).•\n\n* Potential participants meeting the criteria will be identified by Shared Solutions and informed of the study. Interested individuals will contact the investigator either by email or telephone. Enrollment will continue until there are 110 participants starting glatiramer acetate (Copaxone®).\n* Potential participants will be informed of the details of the study, eligibility will be confirmed, and participant's questions answered.\n* The two study instruments and the sociodemographic questionnaire will be emailed or mailed via UPS along with an information letter. May be returned either via email, fax or UPS mail.\n* At month 6 for each participant, the study instruments and sociodemographic questionnaire will be sent a second time and returned to the investigator."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with Multiple Sclerosis living in the community', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stopped interferon (beta-1a or beta-1b) within the past 30 days\n* About to start or started glatiramer acetate (Copaxone®) within the past 21 days.\n* At least 18 years of age\n* Has spasticity at the beginning of the study\n* Able to ambulate with unilateral support or without support\n* Understands, speaks and reads English\n\nExclusion Criteria:\n\n* Severe Gait Disability or Total Gait Disability'}, 'identificationModule': {'nctId': 'NCT01111435', 'briefTitle': 'A Prospective Study of Spasticity in Individuals With Multiple Sclerosis', 'organization': {'class': 'INDIV', 'fullName': 'Fraser, Cira, Ph.D., RN, ACNS-BC'}, 'officialTitle': 'A Prospective Study of Spasticity in Individuals With Multiple Sclerosis in Transition From Interferon to Glatiramer Acetate (Copaxone®)', 'orgStudyIdInfo': {'id': 'Spasticity2010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with Multiple Sclerosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Shared Solutions Call Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Cira Fraser, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monmouth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fraser, Cira, Ph.D., RN, ACNS-BC', 'class': 'INDIV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Cira Fraser PhD, RN, ACNS-BC', 'investigatorAffiliation': 'Fraser, Cira, Ph.D., RN, ACNS-BC'}}}}