Nctid:
NCT00000147
Payload:
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{"InterventionBrowseLeafId"=>"M4217", "InterventionBrowseLeafName"=>"Anti-Inflammatory Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9047", "InterventionBrowseLeafName"=>"Glucocorticoids", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9789", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9788", "InterventionBrowseLeafName"=>"Hormone Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20966", "InterventionBrowseLeafName"=>"Antineoplastic Agents, Hormonal", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4251", "InterventionBrowseLeafName"=>"Antiemetics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8881", "InterventionBrowseLeafName"=>"Gastrointestinal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20773", "InterventionBrowseLeafName"=>"Neuroprotective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M21869", "InterventionBrowseLeafName"=>"Protective Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Inflammatory Agents", "InterventionBrowseBranchAbbrev"=>"Infl"}, {"InterventionBrowseBranchName"=>"Antiemetics", "InterventionBrowseBranchAbbrev"=>"AnEm"}, {"InterventionBrowseBranchName"=>"Neuroprotective Agents", "InterventionBrowseBranchAbbrev"=>"NeuroAg"}, {"InterventionBrowseBranchName"=>"Gastrointestinal Agents", "InterventionBrowseBranchAbbrev"=>"Gast"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Not Applicable"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignMaskingInfo"=>{"DesignMasking"=>"Single"}, "DesignPrimaryPurpose"=>"Treatment"}}, "StatusModule"=>{"OverallStatus"=>"Unknown status", "LastKnownStatus"=>"Active, not recruiting", "StartDateStruct"=>{"StartDate"=>"July 1988"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 1999", "LastUpdateSubmitDate"=>"May 26, 2006", "StudyFirstSubmitDate"=>"September 23, 1999", "StudyFirstSubmitQCDate"=>"September 23, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"May 29, 2006", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"September 24, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Multiple Sclerosis", "Optic Neuritis"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"Beck RW; Diehl L; Cleary PA; Optic Neuritis Study Group; The Pelli-Robson Letter Chart: Normative data for young adults., Clin Vis Sci 1993;8:207-210"}, {"ReferencePMID"=>"8500302", "ReferenceType"=>"background", "ReferenceCitation"=>"Cleary PA, Beck RW, Anderson MM Jr, Kenny DJ, Backlund JY, Gilbert PR. Design, methods, and conduct of the Optic Neuritis Treatment Trial. Control Clin Trials. 1993 Apr;14(2):123-42. doi: 10.1016/0197-2456(93)90015-6."}, {"ReferencePMID"=>"8500303", "ReferenceType"=>"background", "ReferenceCitation"=>"Keltner JL, Johnson CA, Beck RW, Cleary PA, Spurr JO. Quality control functions of the Visual Field Reading Center (VFRC) for the Optic Neuritis Treatment Trial (ONTT). Control Clin Trials. 1993 Apr;14(2):143-59. doi: 10.1016/0197-2456(93)90016-7."}, {"ReferencePMID"=>"8932973", "ReferenceType"=>"background", "ReferenceCitation"=>"Anderson MM Jr, Boly LD, Beck RW. Remote clinic/patient monitoring for multicenter trials. Optic Neuritis Study Group. Control Clin Trials. 1996 Oct;17(5):407-14. doi: 10.1016/s0197-2456(96)00021-9."}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Optic Neuritis Study Group; The five-year risk of multiple sclerosis after optic neuritis. Experience of the Optic Neuritis Treatment Trial., Neurology (in press)"}, {"ReferencePMID"=>"9400788", "ReferenceType"=>"background", "ReferenceCitation"=>"Visual function 5 years after optic neuritis: experience of the Optic Neuritis Treatment Trial. The Optic Neuritis Study Group. Arch Ophthalmol. 1997 Dec;115(12):1545-52."}, {"ReferencePMID"=>"1841573", "ReferenceType"=>"background", "ReferenceCitation"=>"The clinical profile of optic neuritis. Experience of the Optic Neuritis Treatment Trial. Optic Neuritis Study Group. Arch Ophthalmol. 1991 Dec;109(12):1673-8. doi: 10.1001/archopht.1991.01080120057025."}, {"ReferencePMID"=>"1734247", "ReferenceType"=>"background", "ReferenceCitation"=>"Beck RW, Cleary PA, Anderson MM Jr, Keltner JL, Shults WT, Kaufman DI, Buckley EG, Corbett JJ, Kupersmith MJ, Miller NR, et al. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med. 1992 Feb 27;326(9):581-8. doi: 10.1056/NEJM199202273260901."}, {"ReferencePMID"=>"1318520", "ReferenceType"=>"background", "ReferenceCitation"=>"Beck RW. Corticosteroid treatment of optic neuritis: a need to change treatment practices. The Optic Neuritis Study Group. Neurology. 1992 Jun;42(6):1133-5. doi: 10.1212/wnl.42.6.1133. No abstract available."}, {"ReferencePMID"=>"1543448", "ReferenceType"=>"background", "ReferenceCitation"=>"Beck RW. The optic neuritis treatment trial. Implications for clinical practice. Optic Neuritis Study Group. Arch Ophthalmol. 1992 Mar;110(3):331-2. doi: 10.1001/archopht.1992.01080150029020. No abstract available."}, {"ReferencePMID"=>"8352671", "ReferenceType"=>"background", "ReferenceCitation"=>"Beck RW, Arrington J, Murtagh FR, Cleary PA, Kaufman DI. Brain magnetic resonance imaging in acute optic neuritis. Experience of the Optic Neuritis Study Group. Arch Neurol. 1993 Aug;50(8):841-6. doi: 10.1001/archneur.1993.00540080050013."}, {"ReferencePMID"=>"8512477", "ReferenceType"=>"background", "ReferenceCitation"=>"Beck RW, Cleary PA. Optic neuritis treatment trial. One-year follow-up results. Arch Ophthalmol. 1993 Jun;111(6):773-5. doi: 10.1001/archopht.1993.01090060061023."}, {"ReferencePMID"=>"8447730", "ReferenceType"=>"background", "ReferenceCitation"=>"Beck RW, Cleary PA. Recovery from severe visual loss in optic neuritis. Arch Ophthalmol. 1993 Mar;111(3):300. doi: 10.1001/archopht.1993.01090030018009. No abstract available."}, {"ReferencePMID"=>"8232485", "ReferenceType"=>"background", "ReferenceCitation"=>"Beck RW, Cleary PA, Trobe JD, Kaufman DI, Kupersmith MJ, Paty DW, Brown CH. The effect of corticosteroids for acute optic neuritis on the subsequent development of multiple sclerosis. The Optic Neuritis Study Group. N Engl J Med. 1993 Dec 9;329(24):1764-9. doi: 10.1056/NEJM199312093292403."}, {"ReferencePMID"=>"8493012", "ReferenceType"=>"background", "ReferenceCitation"=>"Beck RW, Kupersmith MJ, Cleary PA, Katz B. Fellow eye abnormalities in acute unilateral optic neuritis. Experience of the optic neuritis treatment trial. Ophthalmology. 1993 May;100(5):691-7; discussion 697-8. doi: 10.1016/s0161-6420(13)31589-9."}, {"ReferencePMID"=>"8468765", "ReferenceType"=>"background", "ReferenceCitation"=>"Chrousos GA, Kattah JC, Beck RW, Cleary PA. Side effects of glucocorticoid treatment. Experience of the Optic Neuritis Treatment Trial. JAMA. 1993 Apr 28;269(16):2110-2."}, {"ReferencePMID"=>"8431161", "ReferenceType"=>"background", "ReferenceCitation"=>"Keltner JL, Johnson CA, Spurr JO, Beck RW. Baseline visual field profile of optic neuritis. The experience of the optic neuritis treatment trial. Optic Neuritis Study Group. Arch Ophthalmol. 1993 Feb;111(2):231-4. doi: 10.1001/archopht.1993.01090020085029."}, {"ReferencePMID"=>"7800355", "ReferenceType"=>"background", "ReferenceCitation"=>"Beck RW, Cleary PA, Backlund JC. The course of visual recovery after optic neuritis. Experience of the Optic Neuritis Treatment Trial. Ophthalmology. 1994 Nov;101(11):1771-8. doi: 10.1016/s0161-6420(94)31103-1."}, {"ReferencePMID"=>"8031275", "ReferenceType"=>"background", "ReferenceCitation"=>"Keltner JL, Johnson CA, Spurr JO, Beck RW. Visual field profile of optic neuritis. One-year follow-up in the Optic Neuritis Treatment Trial. Arch Ophthalmol. 1994 Jul;112(7):946-53. doi: 10.1001/archopht.1994.01090190094027."}, {"ReferencePMID"=>"7864737", "ReferenceType"=>"background", "ReferenceCitation"=>"Beck RW. The optic neuritis treatment trial: three-year follow-up results. Arch Ophthalmol. 1995 Feb;113(2):136-7. doi: 10.1001/archopht.1995.01100020014004. No abstract available."}, {"ReferencePMID"=>"8574355", "ReferenceType"=>"background", "ReferenceCitation"=>"Beck RW, Trobe JD. The Optic Neuritis Treatment Trial. Putting the results in perspective. The Optic Neuritis Study Group. J Neuroophthalmol. 1995 Sep;15(3):131-5. No abstract available."}, {"ReferencePMID"=>"9097798", "ReferenceType"=>"background", "ReferenceCitation"=>"Beck RW, Trobe JD. What we have learned from the Optic Neuritis Treatment Trial. Ophthalmology. 1995 Oct;102(10):1504-8. doi: 10.1016/s0161-6420(95)30839-1. No abstract available."}, {"ReferencePMID"=>"8614496", "ReferenceType"=>"background", "ReferenceCitation"=>"Rolak LA, Beck RW, Paty DW, Tourtellotte WW, Whitaker JN, Rudick RA. Cerebrospinal fluid in acute optic neuritis: experience of the optic neuritis treatment trial. Neurology. 1996 Feb;46(2):368-72. doi: 10.1212/wnl.46.2.368."}, {"ReferencePMID"=>"8610798", "ReferenceType"=>"background", "ReferenceCitation"=>"Trobe JD, Beck RW, Moke PS, Cleary PA. Contrast sensitivity and other vision tests in the optic neuritis treatment trial. Am J Ophthalmol. 1996 May;121(5):547-53. doi: 10.1016/s0002-9394(14)75429-7."}, {"ReferencePMID"=>"9093956", "ReferenceType"=>"background", "ReferenceCitation"=>"Cleary PA, Beck RW, Bourque LB, Backlund JC, Miskala PH. Visual symptoms after optic neuritis. Results from the Optic Neuritis Treatment Trial. J Neuroophthalmol. 1997 Mar;17(1):18-23; quiz 24-8. doi: 10.1016/s0002-9394(14)70814-1."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis.\n\nTo determine the natural history of vision in patients who suffer optic neuritis.\n\nTo identify risk factors for the development of multiple sclerosis in patients with optic neuritis.", "DetailedDescription"=>"Optic neuritis is an inflammatory disease of the optic nerve that typically affects young adults. Women are affected more often than men. It is second only to glaucoma as the most common acquired optic nerve disorder in persons younger than age 50.\n\nIn this disorder, closely linked to multiple sclerosis, prognosis for visual recovery is generally good. However, return of visual function is almost never complete. After resolution of optic neuritis, virtually all patients show some signs of optic nerve damage, and most are symptomatic. Even when a patient's acuity recovers to 20/20, abnormalities frequently remain in other measures such as contrast sensitivity, color vision, and visual field.\n\nPrior to the Optic Neuritis Treatment Trial (ONTT), well-established guidelines for treating optic neuritis did not exist. Although corticosteroids had been used to treat this disease, studies to demonstrate their effectiveness had not been satisfactory. Some experts advocated treatment with oral prednisone while others recommended no treatment. Anecdotal reports suggested that high-dose intravenous corticosteroids might be effective.\n\nThe association between optic neuritis and multiple sclerosis is well established. Optic neuritis may be the first manifestation of multiple sclerosis, or it may occur later in its course. A strong case can be made for \"isolated\" optic neuritis being a forme fruste of multiple sclerosis, based on similarities between the two in such epidemiologic factors as gender, age, geographic distributions, cerebrospinal fluid changes, histocompatibility data, magnetic resonance imaging (MRI) changes, and family history. The magnitude of the risk of multiple sclerosis after optic neuritis is uncertain. Previous studies have reported very disparate results, with the risk being reported to be as low as 13 percent and as high as 88 percent. The importance of risk factors such as age, gender, and MRI changes in predicting which patients with optic neuritis are most likely to develop multiple sclerosis also is unclear.\n\nThe treatment phase of the study was called the Optic Neuritis Treatment Trial (ONTT), whereas the current long-term followup phase is called the Longitudinal Optic Neuritis Study (LONS). The study is being conducted at 15 clinical centers in the United States. Resource centers include a data coordinating center and a visual field reading center.\n\nPatients were randomized to one of the three following treatment groups at 15 clinical centers:\n\nOral prednisone (1 mg/kg/day) for 14 days\nIntravenous methylprednisolone (250 mg every 6 hours) for 3 days, followed by oral prednisone (1 mg/kg/day) for 11 days\nOral placebo for 14 days.\n\nEach regimen was followed by a short oral taper. The oral prednisone and placebo groups were double masked, whereas the intravenous methylprednisolone group was single masked.\n\nBaseline testing included blood tests to evaluate for syphilis and systemic lupus erythematosus, a chest x-ray to evaluate for sarcoidosis, and a brain MRI scan to evaluate for changes suggestive of multiple sclerosis.\n\nThe rate of visual recovery and the long-term visual outcome were both assessed by measures of visual acuity, contrast sensitivity, color vision, and visual field at baseline, at seven followup visits during the first 6 months, and then yearly. A standardized neurologic examination with an assessment of multiple sclerosis status was made at baseline, after 6 months, and then yearly."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"46 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"The major eligibility criteria for enrollment into the ONTT included the following:\n\nAge range of 18 to 46 years\n\nAcute unilateral optic neuritis with visual symptoms for 8 days or less\n\nA relative afferent pupillary defect and a visual field defect in the affected eye\n\nNo previous episodes of optic neuritis in the affected eye\n\nNo previous corticosteroid treatment for optic neuritis or multiple sclerosis\n\nNo systemic disease other than multiple sclerosis that might be the cause of the optic neuritis"}, "IdentificationModule"=>{"NCTId"=>"NCT00000147", "BriefTitle"=>"Longitudinal Optic Neuritis Study (LONS)", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Eye Institute (NEI)"}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"NEI-48"}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Methylprednisolone", "InterventionType"=>"Drug"}, {"InterventionName"=>"Prednisone", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationCity"=>"Little Rock", "LocationState"=>"Arkansas", "LocationCountry"=>"United States", "LocationFacility"=>"University of Arkansas"}, {"LocationCity"=>"San Francisco", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"California Pacific Medical Center"}, {"LocationCity"=>"Washington", "LocationState"=>"District of Columbia", "LocationCountry"=>"United States", "LocationFacility"=>"Georgetown University"}, {"LocationCity"=>"Gainesville", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"University of Florida"}, {"LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"University of Illinois"}, {"LocationCity"=>"Iowa City", "LocationState"=>"Iowa", "LocationCountry"=>"United States", "LocationFacility"=>"University of Iowa"}, {"LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Johns Hopkins University"}, {"LocationCity"=>"Ann Arbor", "LocationState"=>"Michigan", "LocationCountry"=>"United States", "LocationFacility"=>"University of Michigan"}, {"LocationCity"=>"East Lansing", "LocationState"=>"Michigan", "LocationCountry"=>"United States", "LocationFacility"=>"Michigan State University"}, {"LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"New York University"}, {"LocationCity"=>"Durham", "LocationState"=>"North Carolina", "LocationCountry"=>"United States", "LocationFacility"=>"Duke University"}, {"LocationCity"=>"Portland", "LocationState"=>"Oregon", "LocationCountry"=>"United States", "LocationFacility"=>"Devers Eye Institute"}, {"LocationCity"=>"Philadelphia", "LocationState"=>"Pennsylvania", "LocationCountry"=>"United States", "LocationFacility"=>"Wills Eye Hospital"}, {"LocationCity"=>"Houston", "LocationState"=>"Texas", "LocationCountry"=>"United States", "LocationFacility"=>"Baylor College of Medicine"}, {"LocationCity"=>"Seattle", "LocationState"=>"Washington", "LocationCountry"=>"United States", "LocationFacility"=>"Swedish Medical Center"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Eye Institute (NEI)", "LeadSponsorClass"=>"NIH"}}}}}}
