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Glutathione Peroxidase Mimetic
SPI-1005 400 mg for 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
Awards & highlights
PANIHL Trial Summary
This study is evaluating whether a drug may help prevent hearing loss in individuals who have experienced hearing loss in the past.
Eligible Conditions
- Noise-Induced Hearing Loss
PANIHL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in the Incidence of a Significant Threshold Shift
Secondary outcome measures
Improvement in word recognition score
Other outcome measures
Adverse events
PANIHL 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
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Who is running the clinical trial?
Sound Pharmaceuticals, IncorporatedLead Sponsor
12 Previous Clinical Trials
988 Total Patients Enrolled
Jonathan Kil, MDStudy ChairSOUND PHARMACEUTICALS, INC.
5 Previous Clinical Trials
432 Total Patients Enrolled
Frequently Asked Questions
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