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UNKNOWNPHASE2

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

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)

NCT02779192•Sound Pharmaceuticals, Incorporated

View on ClinicalTrials.gov

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.

Detailed Description

Randomized, double-blind, placebo-controlled, safety and efficacy study of oral SPI-1005 in adults with Noise Induced Hearing Loss (NIHL). All recruited subjects will have their severity of NIHL determined before the start of SPI-1005 treatment using various hearing tests. Subjects will be enrolled and randomized to either placebo or SPI-1005. Subjects will be dosed with either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL. Subjects will have hearing tests performed before and immediately after a calibrated sound challenge (CSC). Follow-up hearing tests will be performed post-CSC.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Adult male or female patients, 18-50 years of age
•History of either recreational and/or occupational exposure to noise
•Voluntarily consent to participate in the study
•Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or intra-uterine device in place for at least 3 months prior to study through study completion; or barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or stable hormonal contraceptive for at least 3 months prior to study through study completion; or surgical sterilization (vasectomy) of partner at least 6 months prior to study.
•Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.

Exclusion Criteria

•Current use or within 60 days prior to study of excluded ototoxic medications
•History of autoimmune inner ear disease
•History of middle ear or inner ear surgery
•Current conductive hearing loss or middle ear effusion
•Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease
•History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen
•Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes
•Participation in another investigational drug or device study within 90 days prior to study enrollment
•Female patients who are pregnant or breastfeeding

Locations (5)

University of Miami

Miami, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

MUSC

Charleston, South Carolina, United States

University of Texas Southwestern

Dallas, Texas, United States

Sound Pharmaceuticals, Inc.

Seattle, Washington, United States

Key Dates

Start Date

November 1, 2018

Primary Completion Date

June 1, 2021

Completion Date

October 1, 2021

Last Updated

August 24, 2018

Enrollment

180

ESTIMATED participants

Conditions

Noise Induced Hearing Loss

Interventions

SPI-1005 200mg

DRUG

SPI-1005 400mg

DRUG

Placebo

DRUG

Contacts

Jonathan Kil, MD

CONTACT

2066342559 jkil@soundpharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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