Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 31 |
| Updated: | 11/24/2017 |
| Start Date: | September 2011 |
| End Date: | March 2014 |
Phase 2 Study of the Safety and Efficacy of an Oral Formulation of SPI-1005 for Prevention of Temporary Auditory Threshold Shift
Exposure to loud sounds can cause hearing loss. The purpose of this research study is to
evaluate potential prevention of temporary changes in hearing that may occur after listening
to music through an iPod or personal music player. We will measure temporary changes in
hearing in subjects who listen to music and take either the study drug, SPI-1005, or a
placebo for 4 days. SPI-1005 is a proprietary preparation of ebselen that allows it to be
taken by mouth. Ebselen contains the mineral selenium and behaves like Glutathione
Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud sounds.
evaluate potential prevention of temporary changes in hearing that may occur after listening
to music through an iPod or personal music player. We will measure temporary changes in
hearing in subjects who listen to music and take either the study drug, SPI-1005, or a
placebo for 4 days. SPI-1005 is a proprietary preparation of ebselen that allows it to be
taken by mouth. Ebselen contains the mineral selenium and behaves like Glutathione
Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud sounds.
Inclusion Criteria:
- Healthy subjects at the time of enrollment.
- 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:
- • Subjects with abnormal hearing levels > 25 dBHL at any tested frequency (250, 500,
1000, 2000, 3000, 4000, 6000 and 8000 Hz) for either ear.
- 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
We found this trial at
1
site
Click here to add this to my saved trials
