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

This study has been completed.
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Sound Pharmaceuticals, Incorporated
ClinicalTrials.gov Identifier:
NCT01444846
First received: September 29, 2011
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Temporary Auditory Threshold Shift
Drug: SPI-1005 Low dose
Drug: SPI-1005 Middle dose
Drug: SPI-1005 High dose
Drug: Placebo
Phase 2

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
Official Title: Phase 2 Study of the Safety and Efficacy of an Oral Formulation of SPI-1005 for Prevention of Temporary Auditory Threshold Shift

Resource links provided by NLM:


Further study details as provided by Sound Pharmaceuticals, Incorporated:

Primary Outcome Measures:
  • Reduction in Temporary Threshold Shift [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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.


Enrollment: 83
Study Start Date: September 2011
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 600mgEbselen
Placebo Comparator: Placebo
0mg SPI-1005, capsule, bid, po, x4d
Drug: Placebo
Oral capsules, 0 mg ebselen, twice daily, 4 days
Other Name: 0 mg Ebselen

  Eligibility

Ages Eligible for Study:   18 Years to 31 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444846

Locations
United States, Florida
University of Florida
Gainsville, Florida, United States, 32610
Sponsors and Collaborators
Sound Pharmaceuticals, Incorporated
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
  More Information

Publications:
Responsible Party: Sound Pharmaceuticals, Incorporated
ClinicalTrials.gov Identifier: NCT01444846     History of Changes
Other Study ID Numbers: SPI-1005-202
Study First Received: September 29, 2011
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sound Pharmaceuticals, Incorporated:
Temporary Auditory Threshold Shift
Hearing Loss
Deafness
SPI-1005
Ebselen

Additional relevant MeSH terms:
Ebselen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014