Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-28 @ 6:38 AM
Study NCT ID:
NCT06340633
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2024-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SPI-1005 in Adults Receiving Cochlear Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'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'}]}}, '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': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-03-25', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effect of SPI-1005 on Residual Low Frequency Hearing', 'timeFrame': '12 months', 'description': 'Residual hearing at low frequencies (≤1000 Hz) using pure tone audiometry'}, {'measure': 'Effect of SPI-1005 on Word Recognition', 'timeFrame': '12 months', 'description': 'Word recognition using words in quiet'}, {'measure': 'Effect of SPI-1005 on Speech Discrimination', 'timeFrame': '12 months', 'description': 'Speech discrimination using words in noise'}, {'measure': 'Effect of SPI-1005 on Tinnitus', 'timeFrame': '12 months', 'description': 'Tinnitus severity using the Tinnitus Functional Index (TFI). TFI Total Score: 0-100, in which a higher score means a worse outcome.'}, {'measure': 'Effect of SPI-1005 on Vertigo', 'timeFrame': '12 months', 'description': 'Vertigo severity using the Vertigo Symptoms Scale (VSS). VSS Total Scale: 0-60, in which a higher score means a worse outcome.'}], 'primaryOutcomes': [{'measure': 'Number of Participants with Treatment Emergent Adverse Events (TEAE)', 'timeFrame': '12 months', 'description': 'Number and severity of adverse events in patients treated with placebo versus SPI-1005.\n\nOutcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hearing Preservation', 'Cochlear Implant', 'SPI-1005', 'Ebselen'], 'conditions': ['Hearing Loss', 'Cochlear Trauma']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.\n\nThe main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005?\n\nThe clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.\n\nParticipants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.\n\nThe effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults who are ≥18 years of age at time of consent.\n* Post-lingual, bilateral, severe to profound sensorineural hearing loss scheduled to receive a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.\n* Air conduction thresholds (decibel hearing loss, dB HL) at baseline in the ear scheduled to receive the cochlear implant:\n\n * ≥40 and ≤70 dB HL at 125, 250, and 500 Hz; AND\n * ≥80 dB HL at 2000 through 8000 Hz.\n* Willing and able to provide informed consent and to perform all behavioral tests as specified per-protocol, including pre-specified reproductive requirements.\n\nExclusion Criteria:\n\n* Current, or within 60 days prior to study enrollment, use of IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.\n* Participation in another investigational drug or device study within 90 days prior to study enrollment.\n* Female patients who are pregnant or breastfeeding.\n* Air conduction thresholds at baseline in the ear scheduled to receive the cochlear implant with any No Response at 125 through 8000 Hz.'}, 'identificationModule': {'nctId': 'NCT06340633', 'briefTitle': 'SPI-1005 in Adults Receiving Cochlear Implant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sound Pharmaceuticals, Incorporated'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Adults Receiving a Cochlear Implant', 'orgStudyIdInfo': {'id': 'SPI-1005-261'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPI-1005 400 mg twice daily (BID)', 'description': 'Oral administration of ebselen (SPI-1005) 400 mg BID for 180 days', 'interventionNames': ['Drug: Ebselen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral administration of matching placebo BID for 180 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ebselen', 'type': 'DRUG', 'otherNames': ['SPI-1005'], 'description': 'Glutathione peroxidase mimetic', 'armGroupLabels': ['SPI-1005 400 mg twice daily (BID)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo containing excipients', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Director', 'role': 'CONTACT', 'phone': '843-792-1356'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Jonathan Kil, MD', 'role': 'CONTACT', 'email': 'info@soundpharma.com', 'phone': '2066342559'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sound Pharmaceuticals, Incorporated', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Med-El Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}