Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift

August 26, 2014 updated by: Sound Pharmaceuticals, Incorporated

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainsville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 29 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SPI-1005 Low dose
200mg SPI-1005, capsule, bid, po, x4d
Drug: SPI-1005 Low dose
Oral capsules, 200 mg ebselen, twice daily, 4 days
Other Names:
  • 200 mg Ebselen
Active Comparator: SPI-1005 Middle Dose
400mg SPI-1005, capsule, bid, po, x4d
Drug: SPI-1005 Middle dose
Oral capsules, 400 mg ebselen, twice daily, 4 days
Other Names:
  • 400 mg Ebselen
Active Comparator: SPI-1005 High Dose
600mg SPI-1005, capsule, bid, po, x4d
Drug: SPI-1005 High dose
Oral capsules, 600 mg ebselen, twice daily, 4 days
Other Names:
  • 600mgEbselen
Placebo Comparator: Placebo
0mg SPI-1005, capsule, bid, po, x4d
Drug: Placebo
Oral capsules, 0 mg ebselen, twice daily, 4 days
Other Names:
  • 0 mg Ebselen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Temporary Threshold Shift
Time Frame: 1 week
Post-sound exposure pure tone audiometry will be compared with baseline (i.e., immediately pre-sound exposure) testing to determine group mean level hearing threshold shift changes between treated and placebo groups.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sound Pharmaceuticals, Incorporated

Collaborators

University of Florida

Investigators

  • Principal Investigator: Colleen Le Prell, PhD, University of Florida
  • Study Director: Jonathan Kil, MD, Sound Pharmaceuticals, Inc
  • Study Director: Eric D Lynch, PhD, Sound Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

September 30, 2011

First Posted (Estimate)

October 3, 2011

Study Record Updates

Last Update Posted (Estimate)

August 28, 2014

Last Update Submitted That Met QC Criteria

August 26, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPI-1005-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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