Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-04-11 @ 10:43 AM
Study NCT ID:
NCT00986960
Status:
WITHDRAWN
Last Update Posted:
2021-01-05
First Post:
2009-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Difficult to recruit due to protocol requirements - participant burden.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-30', 'studyFirstSubmitDate': '2009-09-29', 'studyFirstSubmitQcDate': '2009-09-29', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. on a voxel-wise MTR dynamic mapping of the lesions and NABT in patients with RRMS', 'timeFrame': '1 year', 'description': 'Effect of ACTH in MRI'}], 'secondaryOutcomes': [{'measure': 'To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. in RRMS on anterior optic pathway pathology, as measured by OCT and LCLA in patients with RRMS.', 'timeFrame': '1 year', 'description': 'Effect of ACTH on optic health'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'relapsing remitting', 'RRMS'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether the use of ACTH in addition to Avonex is effective in the treatment of relapsing remitting multiple sclerosis.', 'detailedDescription': 'Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system (CNS). It is a complex, multi-factorial disease that includes inflammatory and neurodegenerative processes manifesting both focally in the form of lesions and diffusely in otherwise normal-appearing brain tissue. Recent data shows that ACTH can have beneficial effects on specific neurodegenerative diseases and it may have superior neuroprotective effects. Adding a regimen of ACTH to standard Avonex treatment may provide neuroprotection and promote remyelination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient diagnosed with MS according to McDonald criteria\n* Age 18-65\n* Have a RR disease course\n* Have EDSS scores 0-5.5\n* Have a disease duration \\<20 years\n* Sub-optimal response to Interferon beta-1a I.M. (Avonex®) while being on therapy for at least 6 months defined as:\n* presence of a documented relapse within the last 12 months\n* or the presence of at least one enhancing T1 Gd lesion on an MRI performed within previous 3 months\n* Signed informed consent\n* Normal kidney functioning (creatinine clearance \\>59)\n* None of the exclusion criteria\n\nExclusion Criteria:\n\n* Presence of relapse or steroid treatment within 60 days prior to study enrollment\n* Presence of neutralizing antibodies to IFNβ-1a I.M. prior to study enrollment\n* Presence of optic neuritis within less than 6 months prior to study enrollment\n* Diagnosis of osteoporosis (T score ≥2.5 SD)\n* Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.\n* Abnormal blood tests, performed during the screening visit including: hepatitis B or hepatitis C, ALT or AST greater than two times the upper limit of normal, abnormal glucose fasting levels or already known diabetes\n* History of depression while on IFNβ-1a I.M.'}, 'identificationModule': {'nctId': 'NCT00986960', 'acronym': 'ACTH', 'briefTitle': 'Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS)', 'organization': {'class': 'OTHER', 'fullName': 'University at Buffalo'}, 'officialTitle': 'Effect of Pulsed ACTH add-on Therapy to Weekly Avonex on Remyelination and Neuroregeneration in Patients With Relapsing Remitting Multiple Sclerosis. A 1-year Placebo-controlled, Double-blinded, Randomized Follow-up Study', 'orgStudyIdInfo': {'id': 'NDA 08-372'}, 'secondaryIdInfos': [{'id': 'NDA 08-372'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adrenocorticotropin hormone', 'description': 'Patients receive the hormone', 'interventionNames': ['Drug: repository corticotropin injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients receive placebo only', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'repository corticotropin injection', 'type': 'DRUG', 'otherNames': ['H.P. Acthar gel'], 'description': 'IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months', 'armGroupLabels': ['Adrenocorticotropin hormone']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo, Buffalo General Hospital', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Robert Zivadinov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Buffalo Neuroimaging Analysis Center'}, {'name': 'Bianca Weinstock-Guttman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jacobs Neurological Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Buffalo Neuroimaging Analysis Center, Professor', 'investigatorFullName': 'Robert Zivadinov, MD, PhD', 'investigatorAffiliation': 'University at Buffalo'}}}}