Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-02-25 @ 7:21 PM
Study NCT ID:
NCT02779192
Status:
UNKNOWN
Last Update Posted:
2018-08-24
First Post:
2016-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006317', 'term': 'Hearing Loss, Noise-Induced'}], 'ancestors': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042986', 'term': 'ebselen'}, {'id': 'D003276', 'term': 'Contraceptives, Oral'}], 'ancestors': [{'id': 'D003271', 'term': 'Contraceptive Agents, Female'}, {'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2016-05-18', 'lastUpdatePostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Within 7 days', 'description': 'Adverse events due to study drug will be compared with placebo'}], 'primaryOutcomes': [{'measure': 'Reduction in the Incidence of a Significant Threshold Shift', 'timeFrame': 'Within 1 day', 'description': 'Post Controlled Sound Challenge pure tone audiometry will be compared with baseline'}], 'secondaryOutcomes': [{'measure': 'Improvement in word recognition score', 'timeFrame': 'Within 1 day', 'description': 'Post Controlled Sound Challenge Words in Noise Test score will be compared with baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Noise Induced Hearing Loss', 'Prevent Acute Noise Induced Hearing Loss'], 'conditions': ['Noise Induced Hearing Loss']}, 'descriptionModule': {'briefSummary': 'SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.', 'detailedDescription': 'Randomized, double-blind, placebo-controlled, safety and efficacy study of oral SPI-1005 in adults with Noise Induced Hearing Loss (NIHL). All recruited subjects will have their severity of NIHL determined before the start of SPI-1005 treatment using various hearing tests. Subjects will be enrolled and randomized to either placebo or SPI-1005. Subjects will be dosed with either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL. Subjects will have hearing tests performed before and immediately after a calibrated sound challenge (CSC). Follow-up hearing tests will be performed post-CSC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female patients, 18-50 years of age\n* History of either recreational and/or occupational exposure to noise\n* Voluntarily consent to participate in the study\n* Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or intra-uterine device in place for at least 3 months prior to study through study completion; or barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or stable hormonal contraceptive for at least 3 months prior to study through study completion; or surgical sterilization (vasectomy) of partner at least 6 months prior to study.\n* Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.\n\nExclusion Criteria:\n\n* Current use or within 60 days prior to study of excluded ototoxic medications\n* History of autoimmune inner ear disease\n* History of middle ear or inner ear surgery\n* Current conductive hearing loss or middle ear effusion\n* Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease\n* History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen\n* Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes\n* Participation in another investigational drug or device study within 90 days prior to study enrollment\n* Female patients who are pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT02779192', 'acronym': 'PANIHL', 'briefTitle': 'A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sound Pharmaceuticals, Incorporated'}, 'officialTitle': 'A Phase 2b, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)', 'orgStudyIdInfo': {'id': 'SPI-1005-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SPI-1005 200 mg', 'description': '200 mg SPI-1005, capsule, bid, po, x7d', 'interventionNames': ['Drug: SPI-1005 200mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SPI-1005 400 mg', 'description': '400 mg SPI-1005, capsule, bid, po, x7d', 'interventionNames': ['Drug: SPI-1005 400mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0 mg SPI-1005, capsule, bid, po, x7d', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SPI-1005 200mg', 'type': 'DRUG', 'otherNames': ['Low Dose'], 'description': 'Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days', 'armGroupLabels': ['SPI-1005 200 mg']}, {'name': 'SPI-1005 400mg', 'type': 'DRUG', 'otherNames': ['High Dose'], 'description': 'Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days', 'armGroupLabels': ['SPI-1005 400 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Control'], 'description': 'Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Michael Hoffer, MD', 'role': 'CONTACT'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66103', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'contacts': [{'name': 'Hinrich Staecker, MD/PhD', 'role': 'CONTACT'}], 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'MUSC', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Joe Kutz, MD', 'role': 'CONTACT'}], 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98103', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Sound Pharmaceuticals, Inc.', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Jonathan Kil, MD', 'role': 'CONTACT', 'email': 'jkil@soundpharma.com', 'phone': '2066342559'}], 'overallOfficials': [{'name': 'Jonathan Kil, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'SOUND PHARMACEUTICALS, INC.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sound Pharmaceuticals, Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}