Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-30 @ 2:58 AM
Study NCT ID:
NCT01039103
Status:
TERMINATED
Last Update Posted:
2016-10-06
First Post:
2009-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-05', 'studyFirstSubmitDate': '2009-12-20', 'studyFirstSubmitQcDate': '2009-12-22', 'lastUpdatePostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4.', 'timeFrame': '4 weeks'}, {'measure': 'Quality of life measured by changes in MSIS-29', 'timeFrame': '12 weeks'}, {'measure': 'Clinical response measured by changes in MSFC', 'timeFrame': '12 weeks'}, {'measure': 'Plasma levels of free prednisolone and prednisolone phosphate', 'timeFrame': '12 weeks'}, {'measure': 'Occurrence of adverse events', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PEG-liposomal prednisolone sodium phosphate'], 'conditions': ['Acute Exacerbation of Remitting Relapsing Multiple Sclerosis', 'Clinically Isolated Syndrome']}, 'descriptionModule': {'briefSummary': 'Patients with an acute exacerbation of Relapsing-Remitting Multiple Sclerosis or with Clinically Isolated Syndrome receive either one single infusion of Nanocort or three daily infusions of SoluMedrol. Main objective is to assess the occurrence of new gadolinium-enhanced T1-weighted lesions at week 8 vs week 1 after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION criteria\n\n* Diagnosis of RRMS (per McDonald criteria, 2005) with dissemination in time and space OR a diagnosis of CIS confirmed by MRI. Patients with CIS who only have optic neuritis will be excluded from this study\n* A maximum Expanded Disability Status Scale (EDSS) score of ≤ 6\n* New neurological symptoms or exacerbation of prior neurological symptoms of over 24 hours duration but \\<7 days duration, verified by neurological examination\n\nEXCLUSION criteria:\n\n* Primary progressive MS.\n* Secondary progressive MS without superimposed relapses.\n* Received systemic corticosteroids within 4 weeks of screening for treatment of MS or other conditions.\n* any contraindication for treatment with (systemic) corticosteroids'}, 'identificationModule': {'nctId': 'NCT01039103', 'briefTitle': 'Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'A Randomized, International, Multi Centre Study to Assess the Efficacy and Safety of Intravenous PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) vs Intravenous Methylprednisolone (Solu-Medrol®) Treatment in Patients With Acute Exacerbation of Relapsing-remitting Multiple Sclerosis or in Patients With Clinically Isolated Syndrome (CIS)', 'orgStudyIdInfo': {'id': 'GLPG0303-CL-204'}, 'secondaryIdInfos': [{'id': '2009-013884-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nanocort', 'description': 'PEG-liposomal prednisolone sodium phosphate (Nanocort) 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1', 'interventionNames': ['Drug: PEG-liposomal prednisolone sodium phosphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Solu-Medrol', 'description': 'Methylprednisolone (Solu-Medrol) 1 g, IV, infusion over 2 hours on days 1, 2 and 3', 'interventionNames': ['Drug: Methylprednisolone']}], 'interventions': [{'name': 'PEG-liposomal prednisolone sodium phosphate', 'type': 'DRUG', 'otherNames': ['Nanocort'], 'description': 'PEG-liposomal prednisolone sodium phosphate 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1', 'armGroupLabels': ['Nanocort']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'otherNames': ['Solu-Medrol'], 'description': 'Methylprednisolone 1 g, IV, infusion over 2 hours on days 1, 2 and 3', 'armGroupLabels': ['Solu-Medrol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'Departement Neurologie AZ St Jan AV', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1820', 'city': 'Melsbroek', 'country': 'Belgium', 'facility': 'Nationaal MS Centrum', 'geoPoint': {'lat': 50.91559, 'lon': 4.47985}}, {'zip': 'B-3900', 'city': 'Overpelt', 'country': 'Belgium', 'facility': 'Revalidatie & MS-centrum Overpelt', 'geoPoint': {'lat': 51.21038, 'lon': 5.41557}}, {'zip': '95445', 'city': 'Bayreuth', 'country': 'Germany', 'facility': 'Krankenhaus Hohe Warte, Neurologische Klinik', 'geoPoint': {'lat': 49.94782, 'lon': 11.57893}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'St. Josef Hospital der Ruhr', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum Rechts der Isar der technischen Universitaet Muenchen, Neurologische Klinik und Poliklinik', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '15-276', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny w Białymstoku', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '40-594', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Diagnomed-Clinical Research Sp. z o.o.', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}], 'overallOfficials': [{'name': 'Johan Beetens, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}