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SPI-1005 Middle Dose for Hearing Loss

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 12 months
Awards & highlights

Study Summary

Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

Eligible Conditions
  • Hearing Loss
  • Tinnitus
  • Ototoxicity
  • Lung Cancer
  • Head and Neck Cancers
  • Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events
Secondary outcome measures
Reduction of hearing loss incidence and severity
Reduction of tinnitus incidence and severity.

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: SPI-1005 Middle DoseActive Control1 Intervention
400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Group II: SPI-1005 High DoseActive Control1 Intervention
600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Group III: SPI-1005 Low DoseActive Control1 Intervention
200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Group IV: PlaceboPlacebo Group1 Intervention
0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

Find a Location

Who is running the clinical trial?

Sound Pharmaceuticals, IncorporatedLead Sponsor
12 Previous Clinical Trials
1,088 Total Patients Enrolled
3 Trials studying Hearing Loss
252 Patients Enrolled for Hearing Loss
VA Puget Sound Health Care SystemFED
65 Previous Clinical Trials
227,712 Total Patients Enrolled
Jonathan Kil, MDStudy DirectorSound Pharmaceuticals, Inc.
5 Previous Clinical Trials
532 Total Patients Enrolled
1 Trials studying Hearing Loss
180 Patients Enrolled for Hearing Loss

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss
2018. "SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01451853.
All > Hearing Loss
~11 spots leftby Apr 2025
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