Otoprotection With SPI-1005

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01444846
• Date of registration: 29/09/2011
• Primary sponsor: Sound Pharmaceuticals, Incorporated
• Public title: Otoprotection With SPI-1005
• Scientific title: Phase 2 Study of the Safety and Efficacy of an Oral Formulation of SPI-1005 for Prevention of Temporary Auditory Threshold Shift
• Date of first enrolment: September 2011
• Target sample size: 80
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01444846
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Colleen Le Prell, PhD

• Name: Colleen Le Prell, PhD

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 31 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Temporary Auditory Threshold Shift

Intervention(s)

Drug: Placebo

Drug: SPI-1005 High dose

Drug: SPI-1005 Low dose

Drug: SPI-1005 Middle dose

Primary Outcome(s)

Reduction in Temporary Threshold Shift [Time Frame: 1 week]

Secondary ID(s)

SPI-1005-202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Florida