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A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss

NCT02779192 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-08-24

No results posted yet for this study

Summary

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.

Conditions

  • Noise Induced Hearing Loss

Interventions

DRUG

SPI-1005 200mg

Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days

DRUG

SPI-1005 400mg

Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days

DRUG

Placebo

Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days

Sponsors & Collaborators

  • Sound Pharmaceuticals, Incorporated

    lead INDUSTRY

Principal Investigators

  • Jonathan Kil, MD · SOUND PHARMACEUTICALS, INC.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2021-06-30
Completion
2021-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02779192 on ClinicalTrials.gov