Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-01 @ 1:23 PM
Study NCT ID:
NCT00856635
Status:
COMPLETED
Last Update Posted:
2018-02-06
First Post:
2009-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'D000068717', 'term': 'Glatiramer Acetate'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'scott.kolodny@tevapharm.com', 'phone': '440-327-1811', 'title': 'Scott Kolodny, M.D.', 'organization': 'Teva Pharmaceuticals, Medical Affairs'}, 'certainAgreement': {'otherDetails': "Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Enrollment did not meet expectations, and target sample sizes were not met.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Glatiramer Acetate', 'description': 'Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injection once a day for up to 6 months.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Retinal Nerve Fiber Layer Thickness at Baseline and Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glatiramer Acetate', 'description': 'Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injection once a day for up to 6 months.'}], 'classes': [{'title': 'Baseline (n=18, 18)', 'categories': [{'measurements': [{'value': '128.1', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '130.5', 'spread': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=13, 13)', 'categories': [{'measurements': [{'value': '89.5', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '88.0', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Axonal loss in the optic nerve (due to optic neuritis) was assessed by measuring retinal nerve fiber thickness of the affected eye using optical coherence tomography (OCT) at Baseline and Month 6.', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified ITT intent-to-treat (mITT) analysis set included all patients who had been randomized to the study, received at least one dose of study drug, had a baseline OCT evaluation, and had at least one non-missing post-baseline OCT evaluation.'}, {'type': 'SECONDARY', 'title': 'To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glatiramer Acetate', 'description': 'Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.\n\nGlatiramer Acetate: 20 mg injected daily subcutaneously'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injection once a day for up to 6 months.\n\nplacebo: injected daily subcutaneously'}], 'timeFrame': '6 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrollment did not meet expectations, and target sample sizes were not met. As a results, the secondary outcome was not analyzed. There were no data collected for this outcome; there is no data to analyze.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Glatiramer Acetate', 'description': 'Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injection once a day for up to 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Discontinued at Randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Glatiramer Acetate', 'description': 'Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injection once a day for up to 6 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '34.4', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The safety analysis set included all patients who had been randomized to the study and received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2009-03-04', 'resultsFirstSubmitDate': '2013-07-11', 'studyFirstSubmitQcDate': '2009-03-05', 'lastUpdatePostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-09-20', 'studyFirstPostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal Nerve Fiber Layer Thickness at Baseline and Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'Axonal loss in the optic nerve (due to optic neuritis) was assessed by measuring retinal nerve fiber thickness of the affected eye using optical coherence tomography (OCT) at Baseline and Month 6.'}], 'secondaryOutcomes': [{'measure': 'To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Optic Neuritis']}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to determine whether glatiramer acetate 20 mg once daily reduces the amount of axonal loss in the optic nerve after a first event of acute optic neuritis compared to placebo patients and to generate data supporting the potential neuroprotective effect of glatiramer acetate in a human in vivo model of axonal loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 18 - 45 years\n* Isolated, unilateral, first acute optic neuritis (AON) event consistent with inflammatory demyelinization, not explained by other etiologies. Onset of AON is defined by the presentation of visual disturbances.\n* Able to provide written informed consent prior to enrollment\n* Willing and able to comply with the protocol requirements for the duration of the study\n* For women of child bearing potential:\n\n * A negative urine pregnancy test o\n * Willing to practice an acceptable method of birth control •\n* Willing to receive a steroidal regimen\n\nExclusion Criteria:\n\n* A diagnosis of clinically definite multiple sclerosis (MS) (Clinically Definite Multiple Sclerosis)\n* Current use of any approved disease modifying agents for treatment of MS\n* Prior clinical episode of optic neuritis in either eye\n* Bilateral AON\n* Inability to undergo study evaluations in both eyes\n* Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function\n* Retrogeniculate visual loss\n* Refractive error of greater than +6 or -6 diopters\n* Neuromyelitis Optica (Devic's disease)\n* Systemic diseases that cause inflammatory optic neuropathy, including but not limited to Sarcoidosis, Systemic lupus erythematosus (SLE), Wegener's Granulomatosis, Syphilis, human immunodeficiency virus (HIV)\n* Known ocular conditions that preclude dilation\n* Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading\n* Any condition that precludes administration of Glatiramer Acetate, such as a known history of sensitivity to mannitol\n* Diabetes Mellitus Types I or II\n* Gastric bypass surgery\n* Current use of chemotherapy or radiotherapy\n* Treatments that may cause visual loss such as plaquenil, anti-tubercular agents, interferon (IFN)-alpha therapy, monoclonal antibodies Cardiac medications that may affect visual evaluations such as digitalis, amiodarone, quinine\n* Ongoing treatment with steroids (for longer than 10 days) within the last 3 months\n* Significant or unstable medical, systemic, psychiatric or logistical condition that affects the patient's ability to give informed consent or to complete the study procedures\n* Use of an investigational drug within 30 days prior to randomization"}, 'identificationModule': {'nctId': 'NCT00856635', 'briefTitle': 'A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON)', 'orgStudyIdInfo': {'id': 'PM030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glatiramer acetate', 'description': 'Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.', 'interventionNames': ['Drug: Glatiramer Acetate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo subcutaneous injection once a day for up to 6 months.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Glatiramer Acetate', 'type': 'DRUG', 'otherNames': ['Copaxone'], 'description': '20 mg injected daily subcutaneously', 'armGroupLabels': ['Glatiramer acetate']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'injected daily subcutaneously', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mark J. Kupersmith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roosevelt Hospital'}, {'name': 'Peter Calabresi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'John Hopkins School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}