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Organoselenium Compound

SPI-1005 Ebselen 200mg Capsule x2 for Ototoxicity

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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks
Awards & highlights

Summary

This trial is testing SPI-1005 to see if it can protect hearing and improve lung function in cystic fibrosis patients who are being treated with an antibiotic for lung infections. The medication might help prevent ear damage and support better lung health.

Eligible Conditions
  • Ototoxicity
  • Hearing Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in lung function
Distortion Product Otoacoustic Emissions
Sensorineural Hearing Loss (disorder)
+4 more
Secondary outcome measures
Pharmacodynamics of Glutathione, cysteine and cystine
Pharmacodynamics of Nrf2
Pharmacogenomics

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SPI-1005 Ebselen 200mg Capsule x3Experimental Treatment1 Intervention
600mg SPI-1005 bid po x 21d High Dose Arm
Group II: SPI-1005 Ebselen 200mg Capsule x2Experimental Treatment1 Intervention
400mg SPI-1005 bid po x 21d Mid Dose Arm
Group III: SPI-1005 Ebselen 200mg Capsule x1Experimental Treatment1 Intervention
200mg SPI-1005 bid po x 21d Low Dose Arm
Group IV: SPI-1000 Capsule 0mg Ebselen PlaceboPlacebo Group1 Intervention
0mg Ebselen SPI-1000 bid po x 21d

Find a Location

Who is running the clinical trial?

Sound Pharmaceuticals, IncorporatedLead Sponsor
12 Previous Clinical Trials
1,088 Total Patients Enrolled
1 Trials studying Ototoxicity
80 Patients Enrolled for Ototoxicity
Medical University of South CarolinaOTHER
947 Previous Clinical Trials
7,397,988 Total Patients Enrolled
1 Trials studying Ototoxicity
105 Patients Enrolled for Ototoxicity
Cystic Fibrosis FoundationOTHER
190 Previous Clinical Trials
37,249 Total Patients Enrolled
~10 spots leftby Sep 2025
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