A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss
Public ClinicalTrials.gov record NCT02779192. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.
Study identification
- NCT ID
- NCT02779192
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2026
- Primary completion
- May 31, 2026
- Completion
- May 31, 2026
- Last update posted
- Jun 2, 2026
2026
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66103 | — |
| MUSC | Charleston | South Carolina | 29425 | — |
| University of Texas Southwestern | Dallas | Texas | 75390 | — |
| Sound Pharmaceuticals, Inc. | Seattle | Washington | 98103 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02779192, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 2, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02779192 live on ClinicalTrials.gov.