Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-02-03 @ 4:35 PM
Study NCT ID:
NCT01399957
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2011-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '15 mL of blood will be collected into an EDTA tube from participants at assessment appointments. Both serum and cells will be frozen and stored in a -80 degree freezer.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-09', 'studyFirstSubmitDate': '2011-07-19', 'studyFirstSubmitQcDate': '2011-07-21', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 25ft walk time', 'timeFrame': 'Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks'}, {'measure': 'Change in 6 minute walk distance', 'timeFrame': 'Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks', 'description': 'Measure of endurance'}], 'secondaryOutcomes': [{'measure': 'Change of Upper extremity dexterity with 9hole peg test', 'timeFrame': 'Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Dalfampridine-ER', 'Walking speed'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Ampyra (dalfampridine-ER) was approved by the FDA (2010) for improving walking speed in persons with multiple sclerosis. This project seeks to determine if there are other benefits to taking dalfampridine besides an increase in walking speed. This is strictly an observational study and research staff will not be involved in any decisions to stop or start taking the medication.', 'detailedDescription': 'Subjects will be evaluated before starting medication, throughout a 14week period after starting D-ER as well as at 12 and 18months following the start date of medication regardless of if they stayed on medication or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons with MS who have been prescribed ampyra at the Mandell Center for Multiple Sclerosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed clinical diagnosis of MS by McDonald criteria\n* Prescribed ampyra (dalfampridine) as part of usual care, but have not yet started taking the medication before baseline visit\n* Receive MS care at the Mandell MS center\n* Cognitively able to understand directions and complete protocol (score of 22 or greater on the MMSE)\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Already began to take drug prior to baseline research visit\n* Not planning to continue care at Mandell Center for at least 14 weeks after initiation of therapy\n* Unwilling or unable to complete assessments'}, 'identificationModule': {'nctId': 'NCT01399957', 'briefTitle': 'Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mount Sinai Rehabilitation Hospital'}, 'officialTitle': 'Responsiveness to Dalfampridine Treatment Among Multiple Sclerosis Patients Followed at the Mandell MS Center: Characterizing Clinical Predictors of Response and Identifying Additional Outcomes', 'orgStudyIdInfo': {'id': 'AL0003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pwMS prescribed dalfampridine-ER', 'description': 'Anyone prescribed D-ER per usual clinical care was recruited into this observational study. All those willing to participate were consented and observed pre-drug and for a 14week period with two follow-up visits scheduled at 12 and 18months.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06112', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Albert Lo, M.D, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital'}, {'name': 'Elizabeth Triche, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Sinai Rehabilitation Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brown University', 'class': 'OTHER'}, {'name': 'Acorda Therapeutics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Manager', 'investigatorFullName': 'Jennifer Ruiz, DPT', 'investigatorAffiliation': 'Mount Sinai Rehabilitation Hospital'}}}}