NCT01444846

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

Completed Phase 2 Results posted Last updated 1 June 2026

What this trial tests

Phase 2 trial testing SPI-1005 Low dose in Temporary Auditory Threshold Shift in 83 participants. Completed in 1 March 2014.

Timeline

1 September 2011

Primary endpoint
1 December 2013

1 March 2014

Quick facts

Lead sponsor	Sound Pharmaceuticals, Incorporated
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	83
Start date	1 September 2011
Primary completion	1 December 2013
Estimated completion	1 March 2014
Sites	1 location across United States

Drugs / interventions tested

• SPI-1005 Low dose — full drug profile →
• SPI-1005 Middle dose — full drug profile →
• SPI-1005 High dose — full drug profile →
• Placebo

Conditions studied

• Temporary Auditory Threshold Shift — all drugs for Temporary Auditory Threshold Shift →

Sponsor

Sound Pharmaceuticals, Incorporated — full company profile →

Who can join

Adults 18 to 31, any sex, with Temporary Auditory Threshold Shift. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Temporary Threshold Shift at 4 kHz--Intent To Treat (ITT) Population
  Time frame: 15 minutes post Controlled Sound Challenge
  The primary efficacy analysis was change in air conduction threshold at 4 kHz collected in the ITT Population on the day of sound exposure. Baseline hearing thresholds were collected on Clinic Visit 2 prior to sound exposure and used in calculating the primary efficacy endpoints. Hearing thresholds after sound exposure were collected and compared to baseline threshold to calculate change from base
• Change in Temporary Threshold Shift at 4 kHz--Per Protocol (PP) Population
  Time frame: 15 minutes post Controlled Sound Challenge
  The primary efficacy analysis was change in air conduction threshold at 4 kHz collected in the PP Population on the day of sound exposure. Baseline hearing thresholds were collected on Clinic Visit 2 prior to sound exposure and used in calculating the primary efficacy endpoints. Hearing thresholds after sound exposure were collected and compared to baseline threshold to calculate change from basel

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial.
   Kil J, Lobarinas E, Spankovich C, Griffiths SK, et al · · 2017 · cited 192× · PMID 28716314 · DOI 10.1016/s0140-6736(17)31791-9
2. Noise-Induced Hearing Loss.
   Natarajan N, Batts S, Stankovic KM. · · 2023 · cited 115× · PMID 36983347 · DOI 10.3390/jcm12062347
3. Emerging therapeutic interventions against noise-induced hearing loss.
   Sha SH, Schacht J. · · 2017 · cited 97× · PMID 27918210 · DOI 10.1080/13543784.2017.1269171
4. CDK2 inhibitors as candidate therapeutics for cisplatin- and noise-induced hearing loss.
   Teitz T, Fang J, Goktug AN, Bonga JD, et al · · 2018 · cited 89× · PMID 29514916 · DOI 10.1084/jem.20172246
5. Apocynin and ebselen reduce influenza A virus-induced lung inflammation in cigarette smoke-exposed mice.
   Oostwoud LC, Gunasinghe P, Seow HJ, Ye JM, et al · · 2016 · cited 69× · PMID 26877172 · DOI 10.1038/srep20983
6. Temporary threshold shift after impulse-noise during video game play: laboratory data.
   Spankovich C, Griffiths SK, Lobariñas E, Morgenstein KE, et al · · 2014 · cited 26× · PMID 24564694 · DOI 10.3109/14992027.2013.865844
7. Associations between dietary quality, noise, and hearing: data from the National Health and Nutrition Examination Survey, 1999-2002.
   Spankovich C, Le Prell CG. · · 2014 · cited 25× · PMID 24975234 · DOI 10.3109/14992027.2014.921340
8. Early investigational drugs for hearing loss.
   Mukherjea D, Ghosh S, Bhatta P, Sheth S, et al · · 2015 · cited 23× · PMID 25243609 · DOI 10.1517/13543784.2015.960076