A Phase 2 interventional study of Placebo and SPI-1005 Ebselen 200mg Capsule x1 in Ototoxicity, sponsored by Sound Pharmaceuticals, Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Sound Pharmaceuticals, Incorporated · Phase 2, Interventional, and Treatment
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing assessments, spirometry, Pharmacokinetic (PK), Physical Exam, Adverse Events (AEs) and Labs baseline to post-treatment.
The secondary objectives of this study are to determine Pharmacogenomics and Pharmacodynamics of SPI-1005.
Randomized, double-blind, placebo-controlled study to evaluate the safety, and efficacy of SPI-1005 in Cystic Fibrosis patients with Acute Pulmonary Exacerbation receiving intravenous tobramycin at risk for ototoxicity. All patients will undergo baseline testing and have their severity of lung function, sensorineural hearing loss, tinnitus and vertigo determined before the start of SPI-1005 treatment. SPI-1005 treatment will start within first two days of IV tobramycin treatment and be administered concomitantly. At the end of the 21-day course of SPI-1005 and 28 days following the cessation of SPI-1005, patients will have their hearing loss, tinnitus and vertigo reassessed. Assessments may also include additional audiometric and pulmonary testing, and additional follow-up testing.
49 studies on the registry are indexed under Ototoxicity; 15 are open to participants now.
This study's enrollment of 35 is below the median of 47 across 33 interventional studies indexed under Ototoxicity.
Browse Ototoxicity 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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
0mg Ebselen SPI-1000 bid po x 21d
Drug: Placebo
200mg SPI-1005 bid po x 21d Low Dose Arm
Drug: SPI-1005 Ebselen 200mg Capsule x1
400mg SPI-1005 bid po x 21d Mid Dose Arm
Drug: SPI-1005 Ebselen 200mg Capsule x2
600mg SPI-1005 bid po x 21d High Dose Arm
Drug: SPI-1005 Ebselen 200mg Capsule x3
0 mg SPI-1005 bid po x 21d
Also known as: SPI-1000
200 mg SPI-1005 bid po x21d
Also known as: SPI-1005 Low Dose
400 mg SPI-1005 bid po x 21d
Also known as: SPI-1005 Mid Dose
600 mg SPI-1005 bid po x 21d
Also known as: SPI-1005 High Dose
Sensorineural Hearing Loss Using Pure-tone Audiometry
Number of participants with ototoxicity: Sensorineural hearing loss using pure-tone audiometry according to the American Speech-Language-Hearing Association (ASHA) criteria for ototoxicity.
Time frame: 4 weeks post-tobramycin
Distortion Product Otoacoustic Emissions
Number of participants with ototoxicity: Decreases in Distortion Product Otoacoustic Emissions (DPOAE), defined as a greater than or equal to 5 dB decrease in DPOAE amplitude in at least one test frequency.
Time frame: 4 weeks post-tobramycin
Speech Discrimination
Number of participants with ototoxicity: Decreases in speech discrimination using the Words in Noise test (WIN) score (0-35, where higher scores are a better outcome), defined as a 10% or greater decrease in WIN score from participant's baseline score.
Time frame: 4 weeks post-tobramycin
Tinnitus Severity
Number of participants with ototoxicity: Increases in Tinnitus Functional Index (TFI) score (0-100, where higher scores are a worse outcome), defined as an increase of 10 points or more from baseline.
Time frame: 4 weeks post-tobramycin
Vertigo Severity
Number of participants with vestibulotoxicity: Increases in Vertigo Symptom Scale - Short Form score (0-60, where higher scores are a worse outcome), defined as an increase of 6 points or more from baseline.
Time frame: 4 weeks post-tobramycin
Changes in Lung Function
Evaluation of lung function using spirometry, assessed using the change from baseline in Forced Expiratory Volume in 1 second (FEV1).
Time frame: 4 weeks post-tobramycin
| Milestone | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 |
|---|---|---|---|---|
| Started | 8 | 8 | 9 | 10 |
| Completed | 7 | 7 | 9 | 8 |
| Not completed | 1 | 1 | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 1 |
Number of participants with ototoxicity: Sensorineural hearing loss using pure-tone audiometry according to the American Speech-Language-Hearing Association (ASHA) criteria for ototoxicity.
| Participants | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 |
|---|---|---|---|---|
| Sensorineural Hearing Loss Using Pure-tone Audiometry | 7 | 6 | 4 | 3 |
Number of participants with ototoxicity: Decreases in Distortion Product Otoacoustic Emissions (DPOAE), defined as a greater than or equal to 5 dB decrease in DPOAE amplitude in at least one test frequency.
| Participants | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 |
|---|---|---|---|---|
| Distortion Product Otoacoustic Emissions | 4 | 5 | 4 | 5 |
Number of participants with ototoxicity: Decreases in speech discrimination using the Words in Noise test (WIN) score (0-35, where higher scores are a better outcome), defined as a 10% or greater decrease in WIN score from participant's baseline score.
| Participants | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 |
|---|---|---|---|---|
| Speech Discrimination | 4 | 2 | 1 | 2 |
Number of participants with ototoxicity: Increases in Tinnitus Functional Index (TFI) score (0-100, where higher scores are a worse outcome), defined as an increase of 10 points or more from baseline.
| Participants | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 |
|---|---|---|---|---|
| Tinnitus Severity | 0 | 0 | 0 | 0 |
Number of participants with vestibulotoxicity: Increases in Vertigo Symptom Scale - Short Form score (0-60, where higher scores are a worse outcome), defined as an increase of 6 points or more from baseline.
| Participants | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 |
|---|---|---|---|---|
| Vertigo Severity | 0 | 2 | 0 | 0 |
Evaluation of lung function using spirometry, assessed using the change from baseline in Forced Expiratory Volume in 1 second (FEV1).
| liters/second | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 |
|---|---|---|---|---|
| Changes in Lung Function | 0.33 ± 0.86 | 0.06 ± 0.35 | 0.14 ± 0.22 | 0.13 ± 0.44 |
Collected over Adverse event data were collected from study consent until 4 weeks post-tobramycin, i.e., approximately 5-7 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SPI-1000 Capsule 0mg Ebselen Placebo | 0/8 (0%) | 3/8 (37.5%) | 4/8 (50%) |
| SPI-1005 Ebselen 200mg Capsule x1 | 0/8 (0%) | 0/8 (0%) | 6/8 (75%) |
| SPI-1005 Ebselen 200mg Capsule x2 | 0/9 (0%) | 0/9 (0%) | 8/9 (88.9%) |
| SPI-1005 Ebselen 200mg Capsule x3 | 0/10 (0%) | 2/10 (20%) | 10/10 (100%) |
| Event | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 |
|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosisInfections and infestations | 3/8 | 0/8 | 0/9 | 0/10 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 0/8 | 0/8 | 0/9 | 1/10 |
| Deep vein thrombosisVascular disorders | 0/8 | 0/8 | 0/9 | 1/10 |
| Event | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 |
|---|---|---|---|---|
| HeadacheNervous system disorders | 0/8 | 2/8 | 2/9 | 3/10 |
| PyrexiaGeneral disorders | 0/8 | 2/8 | 0/9 | 1/10 |
| Infective pulmonary exacerbation of cystic fibrosisInfections and infestations | 1/8 | 0/8 | 2/9 | 1/10 |
| Abdominal pain upperGastrointestinal disorders | 1/8 | 0/8 | 0/9 | 0/10 |
| NauseaGastrointestinal disorders | 0/8 | 1/8 | 0/9 | 1/10 |
| VomitingGastrointestinal disorders | 0/8 | 1/8 | 0/9 | 0/10 |
| Chest painGeneral disorders | 0/8 | 1/8 | 0/9 | 0/10 |
| Face oedemaGeneral disorders | 1/8 | 0/8 | 0/9 | 0/10 |
| Respiratory syncytial virus infectionInfections and infestations | 0/8 | 1/8 | 0/9 | 0/10 |
| Vulvovaginal candidiasisInfections and infestations | 1/8 | 0/8 | 0/9 | 0/10 |
| Age, Continuous(years) | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 | Total |
|---|---|---|---|---|---|
| Mean | 30.0 ± 8.0 | 27.4 ± 10.5 | 27.7 ± 8.0 | 35.2 ± 11.1 | 30.3 ± 9.7 |
| Sex: Female, Male(Participants) | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 | Total |
|---|---|---|---|---|---|
| Female | 6 | 2 | 4 | 4 | 16 |
| Male | 2 | 6 | 5 | 6 | 19 |
| Ethnicity (NIH/OMB)(Participants) | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 2 | 3 |
| Not Hispanic or Latino | 8 | 7 | 9 | 8 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 2 | 0 | 2 |
| White | 8 | 7 | 7 | 9 | 31 |
| More than one race | 0 | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 1 |
| Region of Enrollment(participants) | SPI-1000 Capsule 0mg Ebselen Placebo | SPI-1005 Ebselen 200mg Capsule x1 | SPI-1005 Ebselen 200mg Capsule x2 | SPI-1005 Ebselen 200mg Capsule x3 | Total |
|---|---|---|---|---|---|
| United States | 8 | 8 | 9 | 10 | 35 |
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Studies of the drug tested here: Ebselen
Sound Pharmaceuticals, Incorporated