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)
1 other identifier
interventional
180
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2018
Typical duration for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2016
CompletedFirst Posted
Study publicly available on registry
May 20, 2016
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedAugust 24, 2018
August 1, 2018
2.6 years
May 18, 2016
August 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Improvement in word recognition score
Within 1 day
Other Outcomes (1)
Adverse events
Within 7 days
Study Arms (3)
SPI-1005 200 mg
ACTIVE COMPARATOR200 mg SPI-1005, capsule, bid, po, x7d
SPI-1005 400 mg
ACTIVE COMPARATOR400 mg SPI-1005, capsule, bid, po, x7d
Placebo
PLACEBO COMPARATOR0 mg SPI-1005, capsule, bid, po, x7d
Interventions
Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days
Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Miami
Miami, Florida, 33136, United States
University of Kansas Medical Center
Kansas City, Kansas, 66103, United States
MUSC
Charleston, South Carolina, 29425, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Sound Pharmaceuticals, Inc.
Seattle, Washington, 98103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jonathan Kil, MD
SOUND PHARMACEUTICALS, INC.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2016
First Posted
May 20, 2016
Study Start
November 1, 2018
Primary Completion
June 1, 2021
Study Completion
October 1, 2021
Last Updated
August 24, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share