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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Noise Induced Hearing Loss
• Intervention / Treatment: Drug: SPI-1005 200mg; Drug: SPI-1005 400mg; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jonathan Kil, MD; Phone Number: 2066342559; Email: jkil@soundpharma.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
      • Contact: Michael Hoffer, MD
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • University of Kansas Medical Center
      • Contact: Hinrich Staecker, MD/PhD
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
      • Contact: Joe Kutz, MD
  • Washington
    • Seattle, Washington, United States, 98103
      • Sound Pharmaceuticals, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SPI-1005 200 mg; 200 mg SPI-1005, capsule, bid, po, x7d	Drug: SPI-1005 200mg; Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days; Other Names: Low Dose
Active Comparator: SPI-1005 400 mg; 400 mg SPI-1005, capsule, bid, po, x7d	Drug: SPI-1005 400mg; Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days; Other Names: High Dose
Placebo Comparator: Placebo; 0 mg SPI-1005, capsule, bid, po, x7d	Drug: Placebo; Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in word recognition score	Post Controlled Sound Challenge Words in Noise Test score will be compared with baseline	Within 1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events due to study drug will be compared with placebo	Within 7 days

Collaborators and Investigators

• Sponsor: Sound Pharmaceuticals, Incorporated
• Investigators: Study Chair: Jonathan Kil, MD, Sound Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Acute Noise Induced Hearing Loss; Prevent Acute Noise Induced Hearing Loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss, Sensorineural; Hearing Loss; Deafness; Hearing Loss, Noise-Induced; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gastrointestinal Agents; Neuroprotective Agents; Protective Agents; Anti-Ulcer Agents; Antioxidants; Ebselen
• Other Study ID Numbers: SPI-1005-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No