Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-29 @ 11:02 AM
Study NCT ID:
NCT04774250
Status:
TERMINATED
Last Update Posted:
2025-09-12
First Post:
2021-02-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}}}}, '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': 'D000078305', 'term': 'Zonisamide'}, {'id': 'D002214', 'term': 'Capsules'}, {'id': 'C109691', 'term': 'microcrystalline cellulose'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'buchmanc@wustl.edu', 'phone': '314-362-2914', 'title': 'Dr. Craig Buchman, Lindburg Professor & Chair, Department of Otolaryngology-Head & Neck Surgery', 'organization': 'Washington University in St. Louis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was prematurely terminated due to the low number of eligible subjects (3 subjects); therefore, statistical analyses were not performed.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Documentation of adverse events at all follow-up visits (5-30 minutes post, within 24 hours, and at 30 day visit; follow-up visit 3, 4, and 5).\n\nAdverse events were tracked post dose within 30 minutes, 24 hours, and at 30 days. All adverse events were recorded on an Adverse Events tracking case report form (CRF). Adverse events related to study medication only were tracked.', 'eventGroups': [{'id': 'EG000', 'title': 'Zonisamide', 'description': 'For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).\n\nZonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.\n\nPlacebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Officers With Permanent Threshold Shift (PTS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).\n\nZonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.\n\nPlacebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.'}], 'classes': [{'categories': [{'title': 'PTS-positive participants', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'PTS-negative participants', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days (+/- 3 days) after training', 'description': 'The proportion of PTS-positive subjects defined as the ratio of PTS-positive subjects to total number of subjects within each study arm/group. Subjects defined as PTS-positive will demonstrate an increase in threshold that is ≥10 dB HL at any frequency from 2-6 kHz post-shooting as compared to baseline audiogram.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated. Due to the very low number of subjects in each study group there was no statistical analysis performed; no statistical test, p-value, or parameter estimation can be reported.'}, {'type': 'SECONDARY', 'title': 'Distortion Product Otoacoustic Emissions (DPOAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'ears', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).\n\nZonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.\n\nPlacebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.'}], 'classes': [{'categories': [{'title': 'No Shift', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Shift', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Excluded', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'baseline (before shooting), 30 days (+/-3 days) after training', 'description': 'DPOAE amplitudes are measured to determine threshold shifts. A change is noted in DPOAE amplitude at any frequency that is significantly greater than the stability of each measurement (i.e., 95% confidence interval of each measurement do not overlap).', 'unitOfMeasure': 'ears', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'ears', 'denomUnitsSelected': 'ears', 'populationDescription': "Each participant's left and right ears were analyzed for threshold shifts at 30 days (+/- 3 days) after training."}, {'type': 'SECONDARY', 'title': 'Ultra-high Frequency Audiometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).\n\nZonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.\n\nPlacebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.'}], 'classes': [{'categories': [{'title': 'Experienced a change in ultra-high frequencies greater than 5 dB', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Did not experience a change in ultra-high frequencies greater than 5 dB', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline (before shooting), within 5-10 minutes after shooting and 30 days (+/-3 days) after training', 'description': 'Number of participants that experience a change in ultra-high frequencies greater than 5 dB; to measure for both temporary and permanent high frequency audiometric changes. A significant change is defined for any frequency that is greater than 5 dB HL from baseline thresholds.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated. Due to the very low number of subjects in each study group there was no statistical analysis performed; no statistical test, p-value, or parameter estimation can be reported.'}, {'type': 'SECONDARY', 'title': 'Electrocochleography (ECochG) AP Amplitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).\n\nZonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.\n\nPlacebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.035', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.1025', 'spread': '0.159', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (before shooting) and 30 days (+/-3 days) after training', 'description': 'To measure for changes in ECochG AP amplitude between baseline (before training) visit and 30-days after training visits.', 'unitOfMeasure': 'millivolts (mV)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated. Due to the very low number of subjects in each study group there was no statistical analysis performed; no statistical test, p-value, or parameter estimation can be reported.'}, {'type': 'SECONDARY', 'title': 'Change in Words In Noise (WIN) Test Signal-to-Noise Ratio Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).\n\nZonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.\n\nPlacebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.267', 'spread': '0', 'groupId': 'OG000'}, {'value': '1.933', 'spread': '0.660', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (before shooting) and 30 days (+/-3 days) after training', 'description': 'The WIN test battery consists of 35 words that are presented in a background noise (speech babble) with varying degrees of signal-to-noise ratios (SNR) from 24 dB HL to 0 dB HL. The WIN score will be repeated three times in order to assess test-retest reliability. The total number of words correctly identified will be used to calculate a dB HL S/N threshold by the Spearman-Karber equation at the mean of 50% correct points. Reported information is the change in score between baseline testing and testing 30 days after training.\n\nThis measure assesses the change in signal-to-noise ratio (SNR) threshold, reported in decibels SNR (dB SNR), at which a participant correctly identifies 50% of the words presented in background noise.', 'unitOfMeasure': 'dB SNR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated. Due to the very low number of subjects in each study group there was no statistical analysis performed; no statistical test, p-value, or parameter estimation can be reported.'}, {'type': 'SECONDARY', 'title': 'Electrocochleography (ECochG) Latency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).\n\nZonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.\n\nPlacebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.105', 'spread': '0', 'groupId': 'OG000'}, {'value': '-0.053', 'spread': '0.046', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (before shooting) and 30 days (+/-3 days) after training', 'description': 'To measure for changes in ECochG latency between baseline (before training) visit and 30-days after training visits.', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated. Due to the very low number of subjects in each study group there was no statistical analysis performed; no statistical test, p-value, or parameter estimation can be reported.'}, {'type': 'SECONDARY', 'title': 'Electrocochleography (ECochG) Width', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).\n\nZonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.\n\nPlacebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.295', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.030', 'spread': '0.028', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (before shooting) and 30 days (+/-3 days) after training', 'description': 'To measure for changes in ECochG width between baseline (before training) visit and 30-days after training visits.', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated. Due to the very low number of subjects in each study group there was no statistical analysis performed; no statistical test, p-value, or parameter estimation can be reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zonisamide', 'description': 'For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).\n\nZonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.\n\nPlacebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zonisamide', 'description': 'For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).\n\nZonisamide 100Mg Cap: ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.\n\nPlacebo: The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '0', 'groupId': 'BG000'}, {'value': '37', 'spread': '6', 'groupId': 'BG001'}, {'value': '39', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-23', 'size': 5199822, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-28T15:20', 'hasProtocol': True}, {'date': '2022-04-18', 'size': 714903, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-28T15:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study will be "masked" or "blinded" in the sense that all the study participants and the study team members will be blinded to the assignment in the study groups. Only the pharmacist who will prepare the drug packets and will seal the envelopes, and the programmer not involved with the study who will produce the random treatment assignments and print the labels will know the order of treatments for any subject. An independent medical professional who is not part of the study team will complete the de-identification of the study drug, and a procedure and documentation log will be in place for quality assurance purposes. The ZNS and placebo capsules will look, taste, and smell the same.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind, and placebo-controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2021-02-23', 'resultsFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-22', 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Officers With Permanent Threshold Shift (PTS)', 'timeFrame': '30 days (+/- 3 days) after training', 'description': 'The proportion of PTS-positive subjects defined as the ratio of PTS-positive subjects to total number of subjects within each study arm/group. Subjects defined as PTS-positive will demonstrate an increase in threshold that is ≥10 dB HL at any frequency from 2-6 kHz post-shooting as compared to baseline audiogram.'}], 'secondaryOutcomes': [{'measure': 'Distortion Product Otoacoustic Emissions (DPOAE)', 'timeFrame': 'baseline (before shooting), 30 days (+/-3 days) after training', 'description': 'DPOAE amplitudes are measured to determine threshold shifts. A change is noted in DPOAE amplitude at any frequency that is significantly greater than the stability of each measurement (i.e., 95% confidence interval of each measurement do not overlap).'}, {'measure': 'Ultra-high Frequency Audiometry', 'timeFrame': 'baseline (before shooting), within 5-10 minutes after shooting and 30 days (+/-3 days) after training', 'description': 'Number of participants that experience a change in ultra-high frequencies greater than 5 dB; to measure for both temporary and permanent high frequency audiometric changes. A significant change is defined for any frequency that is greater than 5 dB HL from baseline thresholds.'}, {'measure': 'Electrocochleography (ECochG) AP Amplitude', 'timeFrame': 'baseline (before shooting) and 30 days (+/-3 days) after training', 'description': 'To measure for changes in ECochG AP amplitude between baseline (before training) visit and 30-days after training visits.'}, {'measure': 'Change in Words In Noise (WIN) Test Signal-to-Noise Ratio Threshold', 'timeFrame': 'baseline (before shooting) and 30 days (+/-3 days) after training', 'description': 'The WIN test battery consists of 35 words that are presented in a background noise (speech babble) with varying degrees of signal-to-noise ratios (SNR) from 24 dB HL to 0 dB HL. The WIN score will be repeated three times in order to assess test-retest reliability. The total number of words correctly identified will be used to calculate a dB HL S/N threshold by the Spearman-Karber equation at the mean of 50% correct points. Reported information is the change in score between baseline testing and testing 30 days after training.\n\nThis measure assesses the change in signal-to-noise ratio (SNR) threshold, reported in decibels SNR (dB SNR), at which a participant correctly identifies 50% of the words presented in background noise.'}, {'measure': 'Electrocochleography (ECochG) Latency', 'timeFrame': 'baseline (before shooting) and 30 days (+/-3 days) after training', 'description': 'To measure for changes in ECochG latency between baseline (before training) visit and 30-days after training visits.'}, {'measure': 'Electrocochleography (ECochG) Width', 'timeFrame': 'baseline (before shooting) and 30 days (+/-3 days) after training', 'description': 'To measure for changes in ECochG width between baseline (before training) visit and 30-days after training visits.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss, Noise-Induced']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of zonisamide (ZNS) for the treatment of noise-induced hearing loss in adults.', 'detailedDescription': 'This is a randomized, double-blind, and placebo-controlled study is to test whether zonisamide (ZNS) can treat noise-induced hearing loss in police officers on the range following training and certifications sessions. Participants who meet the eligibility requirements will be randomized to receive either ZNS 100 milligrams (mg) or placebo.\n\nStudy participants will be recruited from the Akron Police Department, Summit County Police Department, and other local surrounding police departments. Police officers will be offered participation if they are training for firearm certification as part of their standard occupational requirements. These are officers that would be recommended and/or required to complete these trainings/certifications despite this investigation and this investigation will have no influence on audiologic recommendations.\n\nAfter being informed about the study expectations and potential risks, all individuals providing written informed consent will undergo screening to determine eligibility for study entry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Screening Inclusion Criteria:\n\n* Police officers who are scheduled for firearm training and/or certification on the range.\n* At least 18 years of age.\n* Air conduction thresholds are to be no worse than 25 dB HL from 0.5 kHz to 3 kHz, no worse than 30 dB HL at 4 kHz, and no worse than 45 dB HL at 6 and 8 kHz prior to shooting range exposure.\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nEnrollment Inclusion Criteria:\n\n* Observed audiometric TTS ≥ 10 dB HL at 2, 3, 4 and/or 6 kHz\n* Observed air-bone gap \\< 10 dB HL at .5, 1, 2 and 4 kHz, with normal tympanometry\n\nExclusion Criteria:\n\n* History of known sulfa allergy or hypersensitivity to carbonic anhydrase inhibitors.\n* History of moderate-to-severe kidney or liver disease.\n* Acute viral, bacterial, fungal or parasitic infection.\n* History of seizures.\n* Currently pregnant or breast-feeding.\n* Any current or history of otologic disorder.\n* History of ototoxic drug use.\n* Current use of strong/moderate 3A4 inhibitor/inducer and grapefruit juice.\n* For secondary outcomes, exclusion criteria is as follows:\n\n 1. DPOAE data will be used as a secondary outcome measure of TTS, and participants will be excluded if their DPOAE is absent at more than 3/7 frequencies. Criteria for a present response is any response that is \\> 5 dB SPL above the noise floor and replicable within ±5 dB SPL.\n 2. ECochG: Participants will be excluded if the ECochG/ABR wave I response is absent.\n 3. WIN test: Participants with WIN scores greater than moderate difficulty or 14.9 dB SNR will be excluded.'}, 'identificationModule': {'nctId': 'NCT04774250', 'acronym': 'PINIHL-AET', 'briefTitle': 'Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment', 'orgStudyIdInfo': {'id': 'PINIHL-AET_UA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zonisamide', 'description': 'For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).', 'interventionNames': ['Drug: Zonisamide 100Mg Cap']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Zonisamide 100Mg Cap', 'type': 'DRUG', 'otherNames': ['Zonegran', 'ZNS'], 'description': 'ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.', 'armGroupLabels': ['Zonisamide']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['microcrystalline cellulose'], 'description': 'The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44325-3001', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Akron', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}], 'overallOfficials': [{'name': 'Craig A Buchman, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'University of Texas', 'class': 'OTHER'}, {'name': 'Gateway Biotechnology, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}