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

Noise Induced Hearing Loss Clinical Trial

— PANIHL  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02779192
• Other study ID #: SPI-1005-203
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2018
• Est. completion date: October 2021

Study information

• Verified date: August 2018
• Source: Sound Pharmaceuticals, Incorporated
• Contact: Jonathan Kil, MD
• Phone: 2066342559
• Email: jkil[@]soundpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: October 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Noise-Induced
• Noise Induced Hearing Loss

Intervention

Drug:
• SPI-1005 200mg
Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days
• SPI-1005 400mg
Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days
• Placebo
Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days

Locations

Country	Name	City	State
United States	MUSC	Charleston	South Carolina
United States	University of Texas Southwestern	Dallas	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Miami	Miami	Florida
United States	Sound Pharmaceuticals, Inc.	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Sound Pharmaceuticals, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Adverse events due to study drug will be compared with placebo	Within 7 days
Primary	Reduction in the Incidence of a Significant Threshold Shift	Post Controlled Sound Challenge pure tone audiometry will be compared with baseline	Within 1 day
Secondary	Improvement in word recognition score	Post Controlled Sound Challenge Words in Noise Test score will be compared with baseline	Within 1 day