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

Phase 2

• Conditions: Noise Induced Hearing Loss
• Interventions: Drug: SPI-1005 200mg; Drug: SPI-1005 400mg; Drug: Placebo

• Registration Number: NCT02779192
• Lead Sponsor: Sound Pharmaceuticals, Incorporated

Brief 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.

Study Timeline

• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-20
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-24
• Study Start: 2018-11
• Primary Completion: 2021-06
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPI-1005 200 mg	SPI-1005 200mg	200 mg SPI-1005, capsule, bid, po, x7d
SPI-1005 400 mg	SPI-1005 400mg	400 mg SPI-1005, capsule, bid, po, x7d
Placebo	Placebo	0 mg SPI-1005, capsule, bid, po, x7d

Primary Outcome Measures

Name	Time	Method
Reduction in the Incidence of a Significant Threshold Shift	Within 1 day	Post Controlled Sound Challenge pure tone audiometry will be compared with baseline

Secondary Outcome Measures

Name	Time	Method
Improvement in word recognition score	Within 1 day	Post Controlled Sound Challenge Words in Noise Test score will be compared with baseline

Trial Locations

Locations (5)

Sound Pharmaceuticals, Inc.; 🇺🇸 Seattle, Washington, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

University of Miami; 🇺🇸 Miami, Florida, United States

MUSC; 🇺🇸 Charleston, South Carolina, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States