Noise Induced Hearing Loss
Conditions
Keywords
Acute Noise Induced Hearing Loss, Prevent Acute Noise Induced Hearing Loss
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.
Interventions
DRUGSPI-1005 200mg
Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days
DRUGSPI-1005 400mg
Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days
DRUGPlacebo
Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days
Sponsors
Sound Pharmaceuticals, Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement in word recognition score | Within 1 day | Post Controlled Sound Challenge Words in Noise Test score will be compared with baseline |
Countries
United States
Contacts
STUDY_CHAIRJonathan Kil, MD
SOUND PHARMACEUTICALS, INC.
Outcome results
None listed