Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT01144351
Status:
TERMINATED
Last Update Posted:
2015-12-14
First Post:
2010-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], '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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2010-06-09', 'studyFirstSubmitQcDate': '2010-06-11', 'lastUpdatePostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT) and determination of the maximum tolerated dose (MTD) in patients with multiple sclerosis (MS).', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC)', 'timeFrame': '12 weeks', 'description': 'Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.'}, {'measure': 'Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions', 'timeFrame': '12 weeks'}, {'measure': 'Reduction in rate of clinical relapses.', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'keywords': ['MS', 'SPMS', 'RRMS', 'Relapsing Forms of Secondary Progressive Multiple Sclerosis (SPMS)', 'or Relapsing-Remitting Multiple Sclerosis (RRMS)'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and tolerability of ELND002 in patients with relapsing forms of secondary progressive multiple sclerosis (SPMS) or relapsing-remitting multiple sclerosis (RRMS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has either clinically definite or laboratory-supported definite relapsing forms of MS for at least 2 years\n* Patients with SPMS or RRMS have documented medical history of relapse in the past year or MRI-documented evidence of MS activity in the past year\n* Has had an inadequate response or intolerability to interferon and/or glatiramer acetate\n* Is able and willing to undergo Gd administration and repeat MRI testing\n\nExclusion Criteria:\n\n* Has primary progressive MS (PPMS)\n* Any history of treatment with recombinant humanized monoclonal antibodies\n* Has received treatment with immunosuppressant medications or experimental agents within 3 months prior to the Baseline\n* A history of opportunistic infection or the presence of any active infection within 3 months prior to Baseline\n* Any history of congestive heart failure or currently has a pacemaker\n* Has a known or suspected hypersensitivity to sulfonamides or any of the components of the investigational drug\n* Has any medical history or psychiatric condition that would impact outcome or study participation\n* Has other clinically significant abnormality on physical, neurological, laboratory, or ECG examination as listed in the protocol during the Screening Phase'}, 'identificationModule': {'nctId': 'NCT01144351', 'briefTitle': 'A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elan Pharmaceuticals'}, 'officialTitle': 'A Phase 1b, Dose-Escalating, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'ELND002-MS103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ELND002', 'description': 'ELND002 sc injection', 'interventionNames': ['Drug: ELND002']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ELND002', 'type': 'DRUG', 'armGroupLabels': ['ELND002']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '60062', 'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44685', 'city': 'Uniontown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.97506, 'lon': -81.40817}}, {'zip': '78258', 'city': 'Cordova', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.15565, 'lon': -89.7762}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'J4V 2J2', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H3A 2B4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elan Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}