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Glutathione Peroxidase Mimetic

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

Phase 2
Waitlist Available
Research Sponsored by Sound Pharmaceuticals, Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 day

Summary

This trial tests SPI-1005, a new pill designed to protect the ears, in adults who have already suffered hearing loss from loud noises. The drug works by mimicking a natural enzyme that helps reduce further hearing damage. SPI-1005, also known as ebselen, is an anti-inflammatory and neuroprotective drug that has shown efficacy in reducing noise-induced and aminoglycoside-induced hearing loss in animals and has demonstrated safety and efficacy in studies for Meniere's disease and acute noise-induced hearing loss.

Eligible Conditions
  • Noise-Induced Hearing Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction in the Incidence of a Significant Threshold Shift
Secondary study objectives
Improvement in word recognition score
Other study objectives
Adverse events

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: SPI-1005 400 mgActive Control1 Intervention
400 mg SPI-1005, capsule, bid, po, x7d
Group II: SPI-1005 200 mgActive Control1 Intervention
200 mg SPI-1005, capsule, bid, po, x7d
Group III: PlaceboPlacebo Group1 Intervention
0 mg SPI-1005, capsule, bid, po, x7d

Find a Location

Who is running the clinical trial?

Sound Pharmaceuticals, IncorporatedLead Sponsor
12 Previous Clinical Trials
948 Total Patients Enrolled
Jonathan Kil, MDStudy ChairSOUND PHARMACEUTICALS, INC.
5 Previous Clinical Trials
392 Total Patients Enrolled
~25 spots leftby Dec 2025
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