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Trial record 1 of 8 for:    Sound Pharmaceuticals, Incorporated
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A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)

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ClinicalTrials.gov Identifier: NCT02779192
Recruitment Status : Not yet recruiting
First Posted : May 20, 2016
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Noise Induced Hearing Loss Drug: SPI-1005 200mg Drug: SPI-1005 400mg Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Control




Primary Outcome Measures :
  1. Reduction in the Incidence of a Significant Threshold Shift [ Time Frame: Within 1 day ]
    Post Controlled Sound Challenge pure tone audiometry will be compared with baseline


Secondary Outcome Measures :
  1. Improvement in word recognition score [ Time Frame: Within 1 day ]
    Post Controlled Sound Challenge Words in Noise Test score will be compared with baseline


Other Outcome Measures:
  1. Adverse events [ Time Frame: Within 7 days ]
    Adverse events due to study drug will be compared with placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779192


Contacts
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Contact: Jonathan Kil, MD 2066342559 jkil@soundpharma.com

Locations
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United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33136
Contact: Michael Hoffer, MD         
United States, Kansas
University of Kansas Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66103
Contact: Hinrich Staecker, MD/PhD         
United States, South Carolina
MUSC
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas Southwestern Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Joe Kutz, MD         
United States, Washington
Sound Pharmaceuticals, Inc.
Seattle, Washington, United States, 98103
Sponsors and Collaborators
Sound Pharmaceuticals, Incorporated
Investigators
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Study Chair: Jonathan Kil, MD SOUND PHARMACEUTICALS, INC.

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Responsible Party: Sound Pharmaceuticals, Incorporated
ClinicalTrials.gov Identifier: NCT02779192     History of Changes
Other Study ID Numbers: SPI-1005-203
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sound Pharmaceuticals, Incorporated:
Acute Noise Induced Hearing Loss
Prevent Acute Noise Induced Hearing Loss

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Noise-Induced
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural