Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift
NCT ID: NCT01444846
Last Updated: 2014-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2011-09-30
2014-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss
NCT02779192
Study to Evaluate SPI-1005 in Adults With Meniere's Disease
NCT02603081
First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
NCT05664100
Prevention of Noise-induced Hearing Loss
NCT02049073
OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
NCT04129775
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SPI-1005 Low dose
200mg SPI-1005, capsule, bid, po, x4d
SPI-1005 Low dose
Oral capsules, 200 mg ebselen, twice daily, 4 days
SPI-1005 Middle Dose
400mg SPI-1005, capsule, bid, po, x4d
SPI-1005 Middle dose
Oral capsules, 400 mg ebselen, twice daily, 4 days
SPI-1005 High Dose
600mg SPI-1005, capsule, bid, po, x4d
SPI-1005 High dose
Oral capsules, 600 mg ebselen, twice daily, 4 days
Placebo
0mg SPI-1005, capsule, bid, po, x4d
Placebo
Oral capsules, 0 mg ebselen, twice daily, 4 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SPI-1005 Low dose
Oral capsules, 200 mg ebselen, twice daily, 4 days
SPI-1005 Middle dose
Oral capsules, 400 mg ebselen, twice daily, 4 days
SPI-1005 High dose
Oral capsules, 600 mg ebselen, twice daily, 4 days
Placebo
Oral capsules, 0 mg ebselen, twice daily, 4 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Each subject will give informed consent to participate in this study and agrees to the treatment protocol.
* Each subject will be interviewed regarding hearing and health to reveal any history of hearing loss, tinnitus, known ear pathology, use of any potentially ototoxic medications (i.e. diuretics, minocycline).
* Non-occupational sound exposure (e.g., concerts, firearms, fireworks, power tools) will be avoided during the 24-hour period preceding baseline testing and throughout the duration of the study.
* Subjects will have vital signs (i.e., heart rate, blood pressure, respirations, temperature) within normal limits upon medical examination.
* Subjects must have normal audiologic assessment at baseline consisting of:
* Baseline audiometric evaluation confirms that subjects have symmetric hearing with air conduction thresholds no worse than 25 decibels of Hearing Loss (dBHL) at frequencies between 0.25 to 8 kilo Hertz (kHz) bilaterally.
* No significant threshold asymmetry (i.e. greater than 15 dB) between the ears at any tested frequency.
* No significant air-bone gaps (i.e. greater than 10 dB)
* Type A tympanograms bilaterally, defined as a range of -140 to +40 dekaPascals (daPa) based on the 90% range for adults (Margolis and Hunter 2000)
Exclusion Criteria
* Exposure to any duration of non-occupational high-level sound (e.g., concerts, firearms, fireworks, power tools) during the 24 hour period preceding baseline audiometric testing as revealed in the subject questionnaire or during the medical examination.
* Pathology of the external ear discovered upon otoscopic examination.
* Pathology of the middle ear revealed by otoscopic examination, abnormal tympanometry, or reported history of middle ear problems.
* Pathology of the inner ear or auditory nerve as revealed by reported history.
* Subject complaints of aural pain, pressure, fullness, or drainage.
* Subjects testing positive for pregnancy will be excluded from the study.
* Subjects with other medical/health issues that would preclude voluntary participation in a drug study may be excluded at the discretion of the Principal Investigator.
* Subjects that have previously received any known potentially ototoxic medication. This includes, but is not limited to, high dose salicylates (\>2 g/day), platinum-based chemotherapeutics and aminoglycoside antibiotics, such as streptomycin, gentamicin,tobramycin, amikacin, neomycin, and netilmycin.
* Subjects that are currently using of any potentially ototoxic medications (i.e. diuretics or minocycline).
* Subjects that have received any investigational treatment (drug or device) in the six months prior to this study.
* Subjects exhibiting or self-reporting shortness of breath, wheezing, coughing, or hemoptysis
18 Years
31 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Florida
OTHER
Sound Pharmaceuticals, Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Colleen Le Prell, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Jonathan Kil, MD
Role: STUDY_DIRECTOR
Sound Pharmaceuticals, Inc
Eric D Lynch, PhD
Role: STUDY_DIRECTOR
Sound Pharmaceuticals, Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Florida
Gainsville, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pourbakht A, Yamasoba T. Ebselen attenuates cochlear damage caused by acoustic trauma. Hear Res. 2003 Jul;181(1-2):100-8. doi: 10.1016/s0378-5955(03)00178-3.
Lynch ED, Gu R, Pierce C, Kil J. Ebselen-mediated protection from single and repeated noise exposure in rat. Laryngoscope. 2004 Feb;114(2):333-7. doi: 10.1097/00005537-200402000-00029.
Lynch ED, Gu R, Pierce C, Kil J. Reduction of acute cisplatin ototoxicity and nephrotoxicity in rats by oral administration of allopurinol and ebselen. Hear Res. 2005 Mar;201(1-2):81-9. doi: 10.1016/j.heares.2004.08.002.
Yamasoba T, Pourbakht A, Sakamoto T, Suzuki M. Ebselen prevents noise-induced excitotoxicity and temporary threshold shift. Neurosci Lett. 2005 Jun 3;380(3):234-8. doi: 10.1016/j.neulet.2005.01.047. Epub 2005 Feb 1.
Lynch ED, Kil J. Compounds for the prevention and treatment of noise-induced hearing loss. Drug Discov Today. 2005 Oct 1;10(19):1291-8. doi: 10.1016/S1359-6446(05)03561-0.
Kil J, Pierce C, Tran H, Gu R, Lynch ED. Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase. Hear Res. 2007 Apr;226(1-2):44-51. doi: 10.1016/j.heares.2006.08.006. Epub 2006 Oct 6.
Lynch E, Kil J. Development of Ebselen, a Glutathione Peroxidase Mimic, for the Prevention and Treatment of Noise-Induced Hearing Loss. Semin Hear 2009; 30(1): 047-055
Le Prell CG, Yang Q, Harris JG. Modification of digital music files for use in human temporary threshold shift studies. J Acoust Soc Am. 2011 Oct;130(4):EL142-6. doi: 10.1121/1.3630017.
Le Prell CG, Dell S, Hensley B, Hall JW 3rd, Campbell KC, Antonelli PJ, Green GE, Miller JM, Guire K. Digital music exposure reliably induces temporary threshold shift in normal-hearing human subjects. Ear Hear. 2012 Nov-Dec;33(6):e44-58. doi: 10.1097/AUD.0b013e31825f9d89.
Kil J, Lobarinas E, Spankovich C, Griffiths SK, Antonelli PJ, Lynch ED, Le Prell CG. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017 Sep 2;390(10098):969-979. doi: 10.1016/S0140-6736(17)31791-9. Epub 2017 Jul 14.
Spankovich C, Le Prell CG. Associations between dietary quality, noise, and hearing: data from the National Health and Nutrition Examination Survey, 1999-2002. Int J Audiol. 2014 Nov;53(11):796-809. doi: 10.3109/14992027.2014.921340. Epub 2014 Jun 30.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPI-1005-202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.