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SPI-1005 for Prevention and Treatment of Chemotherapy Induced 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 up to 5 years
Summary
This trial tests SPI-1005, an oral medication, to prevent hearing loss and tinnitus in cancer patients receiving platinum-based chemotherapy. The treatment works by reducing harmful substances that can damage hearing.
Eligible Conditions
- Head and Neck Cancers
- Hearing Loss
- Tinnitus
- Ototoxicity
- Lung Cancer
- Neuropathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: SPI-1005 High DoseActive Control1 Intervention
600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Group II: SPI-1005 Middle DoseActive Control1 Intervention
400 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
1,048 Total Patients Enrolled
3 Trials studying Hearing Loss
252 Patients Enrolled for Hearing Loss
VA Puget Sound Health Care SystemFED
65 Previous Clinical Trials
224,704 Total Patients Enrolled
Jonathan Kil, MDStudy DirectorSound Pharmaceuticals, Inc.
5 Previous Clinical Trials
492 Total Patients Enrolled
1 Trials studying Hearing Loss
180 Patients Enrolled for Hearing Loss