Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
Study NCT ID:
NCT00000361
Status:
TERMINATED
Last Update Posted:
2006-04-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autoimmunity in Inner Ear Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1998-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-04', 'completionDateStruct': {'date': '2002-11'}, 'lastUpdateSubmitDate': '2006-04-21', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '1999-11-02', 'lastUpdatePostDateStruct': {'date': '2006-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-11-03', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Autoimmune Diseases', 'Cyclophosphamide', 'Hearing', 'Labyrinth Diseases', 'Methotrexate', 'Prednisone'], 'conditions': ['Hearing Loss, Sensorineural']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing loss in both ears. This condition is called autoimmune inner ear disease (AIED), because it is thought that the hearing loss is triggered by an autoimmune process. Treatment attempts to suppress or control this process with powerful anti-inflammatory drugs. This is a Phase III, outpatient study. All study participants will be assigned to one of four different groups testing the experimental use of drugs. The study is scheduled to run for 18 months, with a minimum of 11 visits per participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have sensorineural (nerve/inner ear) hearing loss of at least 30 dB in each ear, which has rapidly progressed.\n* Are in good general health.\n* Are sterile or use contraception (if a woman of child-bearing age).\n* Are able to speak and understand English or Spanish.\n\nExclusion Criteria:\n\n* Have had any previous reaction to prednisone, or history of psychiatric reaction to corticosteroids.\n* Have used corticosteroids for more than 30 days within the past 90 days. Patients who have been off corticosteroids for at least 30 days may be eligible.\n* Have any significant heart, lung, digestive, blood, or neurologic disorders.\n* Have tuberculosis (TB), brittle or unstable insulin-dependent diabetes mellitus, active malignancy or prior chemotherapy, pancreatitis, active peptic ulcer disease, kidney failure, history of shingles, or known (other) autoimmune disease.\n* Have had a positive test for HIV, hepatitis C or B.\n* Have any type of middle ear disorder.\n* Are breast-feeding or pregnant.'}, 'identificationModule': {'nctId': 'NCT00000361', 'briefTitle': 'Autoimmunity in Inner Ear Disease', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Deafness and Other Communication Disorders (NIDCD)'}, 'orgStudyIdInfo': {'id': 'NIDCD-1158'}, 'secondaryIdInfos': [{'id': 'U01DC003209', 'link': 'https://reporter.nih.gov/quickSearch/U01DC003209', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Corticosteroids', 'type': 'DRUG'}, {'name': 'Methotrexate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'House Ear Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103-8895', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '52242-1078', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Univ of Iowa Hosp and Clinic', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '21287-0008', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Univ', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Eye and Ear Infirmary', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109-0005', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Univ of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195-5245', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Dr. Jeffrey Harris', 'role': 'STUDY_CHAIR'}, {'name': 'Dr. Patrick Brookhouser', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}}}}