A Phase 2 interventional study of SPI-1005 Low Dose and SPI-1005 Middle Dose in Lung Cancer, Head and Neck Cancer and Hearing Loss, sponsored by Sound Pharmaceuticals, Incorporated. Withdrawn at 1 site in United States. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Sound Pharmaceuticals, Incorporated · Phase 2, Interventional, and Treatment
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.
Chemotherapy treatment with the platinum containing chemotherapies (e.g. cisplatin, carboplatin) are well noted and studied for their ability to cause ototoxicity which includes hearing loss, tinnitus, vertigo, or dizziness. 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 for head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.
SPI-1005, a proprietary oral formulation of ebselen is a small molecule mimic and inducer of the enzyme Glutathione Peroxidase. GPx reduces reactive oxygen species (ROS) by reacting with glutathione. SPI-1005 has been shown to reduce cisplatin induced hearing threshold shift in animal studies.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
Browse Lung Neoplasms studies →Sound Pharmaceuticals, Incorporated is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Drug: SPI-1005 Low Dose
400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Drug: SPI-1005 Middle Dose
600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Drug: SPI-1005 High Dose
0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy
Drug: Placebo
Oral capsules, 200 mg ebselen, twice daily, 3 days for each cycle of chemotherapy Arms: Low Dose Other Names: 200 mg Ebselen
Also known as: 200 mg Ebselen
Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Also known as: 400 mg Ebselen
Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Also known as: 600 mg Ebselen
Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
Also known as: 0 mg Ebselen
Number of participants with adverse events
Time frame: 12 months
Reduction of hearing loss incidence and severity
Time frame: From baseline through 1 month after last chemotherapy cycle
Reduction of tinnitus incidence and severity.
Time frame: From baseline through 1 month after last chemotherapy cycle
This study is withdrawn, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ebselen
Sound Pharmaceuticals, Incorporated