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Trial record 1 of 10 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

Tracking Information
First Submitted Date  ICMJE May 18, 2016
First Posted Date  ICMJE May 20, 2016
Last Update Posted Date August 24, 2018
Estimated Study Start Date  ICMJE November 2018
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 18, 2016)
Reduction in the Incidence of a Significant Threshold Shift [ Time Frame: Within 1 day ]
Post-CSC pure tone audiometry will be compared with baseline
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
Improvement in word recognition score [ Time Frame: Within 1 day ]
Post Controlled Sound Challenge Words in Noise Test score will be compared with baseline
Original Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2016)
Improvement in word recognition score [ Time Frame: Within 1 day ]
Post-CSC Words in Noise Test scores will be compared with baseline
Current Other Pre-specified Outcome Measures
 (submitted: May 18, 2016)
Adverse events [ Time Frame: Within 7 days ]
Adverse events due to study drug will be compared with placebo
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss
Official Title  ICMJE 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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Noise Induced Hearing Loss
Intervention  ICMJE
  • Drug: SPI-1005 200mg
    Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days
    Other Name: Low Dose
  • Drug: SPI-1005 400mg
    Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days
    Other Name: High Dose
  • Drug: Placebo
    Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days
    Other Name: Control
Study Arms  ICMJE
  • Active Comparator: SPI-1005 200 mg
    200 mg SPI-1005, capsule, bid, po, x7d
    Intervention: Drug: SPI-1005 200mg
  • Active Comparator: SPI-1005 400 mg
    400 mg SPI-1005, capsule, bid, po, x7d
    Intervention: Drug: SPI-1005 400mg
  • Placebo Comparator: Placebo
    0 mg SPI-1005, capsule, bid, po, x7d
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 18, 2016)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jonathan Kil, MD 2066342559 jkil@soundpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02779192
Other Study ID Numbers  ICMJE SPI-1005-203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sound Pharmaceuticals, Incorporated
Study Sponsor  ICMJE Sound Pharmaceuticals, Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jonathan Kil, MD SOUND PHARMACEUTICALS, INC.
PRS Account Sound Pharmaceuticals, Incorporated
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP