Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT01987167
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2013-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009902', 'term': 'Optic Neuritis'}], 'ancestors': [{'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000324', 'term': 'Adrenocorticotropic Hormone'}], 'ancestors': [{'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2013-11-06', 'studyFirstSubmitQcDate': '2013-11-12', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Preservation and/or restoration of electrophysiological parameters for patients with acute optic neuritis.', 'timeFrame': '12 months', 'description': 'To define the electrophysiological changes at the onset and following an acute event of optic neuritis with Multifocal electroretinography(mERG) and visual evoked potentials (VEP)'}, {'measure': 'Structural, Physiological and Metabolic changes during an acute event of optic neuritis', 'timeFrame': '12 months', 'description': 'to determine the earliest structural, physiological, and metabolic changes in the optic nerve during an acute event of demyelinating optic neuritis and the natural history of these changes over 6 months.'}], 'primaryOutcomes': [{'measure': 'Neuro-protection', 'timeFrame': '12 months', 'description': 'Functional with low contrast visual acuity in bothe the eye acutely affected by optic neuritis and the clinically unaffected eye.'}], 'secondaryOutcomes': [{'measure': 'Preservation of retinal nerve fiber layer.', 'timeFrame': '12 months', 'description': 'To define the objective (micron thickness, volumetric analysis) and subjective (histopathological changes) of spectral domain optical coherence tomography (SD-OCT) at the time of clinical presentation of acute optic neuritis and during 6 months of recovery following ACTHAR treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute optic neuritis'], 'conditions': ['Optic Neuritis']}, 'referencesModule': {'references': [{'pmid': '28538037', 'type': 'RESULT', 'citation': 'Moster ML, Sergott RC, Leiby BE. Dalfampridine Treatment in Nonarteritic Anterior Ischemic Optic Neuropathy. J Neuroophthalmol. 2017 Sep;37(3):348-349. doi: 10.1097/WNO.0000000000000523. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the study is to determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.', 'detailedDescription': 'Determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral acute demyelinating optic neuritis\n* Able to provide informed consent\n* age 18 or older\n* can perform the above listed electrophysiologic diagnostic testing\n* can perform high and low contrast visual acuity and visual field perimetry\n\nExclusion Criteria:\n\n* prior diagnosis of remitting/relapsing multiple sclerosis(RRMS)\n* secondary progressive MS(SPMS)\n* primary progressive MS (PPMS)\n* undergoing treatment with medications approve for treatment of RRMS(except corticosteroids for a condition not involving central nervous system demyelination)\n* prior diagnosis of systemic lupus erythematosis\n* mixed connective tissue disease\n* vasculitis\n* sarcoidosis\n* neuro-myelitis optica'}, 'identificationModule': {'nctId': 'NCT01987167', 'acronym': 'ACHTAR', 'briefTitle': 'Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis', 'organization': {'class': 'OTHER', 'fullName': 'Neuro-Ophthalmologic Associates, PC'}, 'officialTitle': 'Potential Neuroprotection With ACTHAR Following Acute Optic Neuritis', 'orgStudyIdInfo': {'id': '13-330'}, 'secondaryIdInfos': [{'id': 'ACTHAR', 'type': 'OTHER', 'domain': 'Questcor Pharmaceuticals, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '-ACHTHAR', 'description': 'Subcutaneous ACTHAR 5 days of 80 IU and 10 Days of 40 IU', 'interventionNames': ['Drug: ACTHAR']}], 'interventions': [{'name': 'ACTHAR', 'type': 'DRUG', 'otherNames': ['Repository Corticotropin'], 'description': 'Injectable Gel', 'armGroupLabels': ['-ACHTHAR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Neuro Ophthalmology', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Robert C Sergott, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuro-Ophthalmologic Associates, PC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mallinckrodt', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}