Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-09 @ 5:53 AM
Study NCT ID:
NCT05776459
Status:
RECRUITING
Last Update Posted:
2025-02-03
First Post:
2023-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of AC102 Compared to Steroids in Adults with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D046088', 'term': 'Hearing Loss, Unilateral'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2023-03-03', 'studyFirstSubmitQcDate': '2023-03-17', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pure tone audiometry (PTA; dB)', 'timeFrame': '28 days', 'description': 'Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28'}], 'secondaryOutcomes': [{'measure': 'Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists', 'timeFrame': '14, 28, 56, 84 days', 'description': 'Scores between 0% to 100% correctly understood words at predefined sound pressure levels are determined'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hearing Loss', 'Hearing impairment', 'Hearing Loss, Sensorineural', 'Ear Diseases', 'Otorhinolaryngologic Diseases', 'Hearing Loss, Unilateral', 'Intratympanic Administration', 'Restoration of Hearing Loss'], 'conditions': ['Hearing Loss, Sensorineural']}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged between 18 and 85 years\n* Unilateral ISSNHL\n* Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization\n* An absolute air conduction hearing threshold of at least 65 dB,\n* Patients with a relative hearing loss of at least 30 dB compared to the current audiogram of the non-affected ear\n\nExclusion Criteria:\n\n* Insufficient handling of the language used in the speech audiometry tests\n* Bilateral hearing loss\n* Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time\n* Congenital hearing loss\n* Conductive hearing loss or combined hearing loss determined by a 4PTA \\> 10 dB\n* History of ISSNHL in the past 1 years in the affected ear'}, 'identificationModule': {'nctId': 'NCT05776459', 'briefTitle': 'Efficacy and Safety of AC102 Compared to Steroids in Adults with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AudioCure Pharma GmbH'}, 'officialTitle': 'Phase II, Multi-Center, Randomized, Blinded Study Evaluating the Efficacy, Safety and Tolerability of a Single Intratympanic Dose of AC102 Compared to Oral Steroids for the Treatment of Idiopathic Sudden Sensorineural Hearing Loss', 'orgStudyIdInfo': {'id': 'AC102-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AC102', 'description': 'AC102 gel and placebo tablets', 'interventionNames': ['Drug: AC102 gel', 'Other: Placebo Tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisolone', 'description': 'Placebo gel and prednisolone tablets', 'interventionNames': ['Drug: Prednisolone', 'Other: Placebo gel']}], 'interventions': [{'name': 'AC102 gel', 'type': 'DRUG', 'description': 'Drug: AC102 Single intratympanic injection', 'armGroupLabels': ['AC102']}, {'name': 'Prednisolone', 'type': 'DRUG', 'description': 'Active comparator: Prednisolone Tablets taken daily by mouth', 'armGroupLabels': ['Prednisolone']}, {'name': 'Placebo Tablets', 'type': 'OTHER', 'description': 'Placebo Tablets taken daily by mouth', 'armGroupLabels': ['AC102']}, {'name': 'Placebo gel', 'type': 'OTHER', 'description': 'Placebo Single intratympanic injection', 'armGroupLabels': ['Prednisolone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '4010', 'city': 'Linz', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Ordensklinikum Linz GmbH Barmherzige Schwestern', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '5020', 'city': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Universitätsklinik für Hals-Nasen-Ohren-Krankheiten', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '500 05', 'city': 'Hradec Králové', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Fakultní nemocnice Hradec Králové', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '779 00', 'city': 'Olomouc', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Zdravotnická zařízení Olomouc, ORL', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': 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