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This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.
Randomized, double-blind, placebo-controlled safety, pharmacokinetic, pharmacodynamic study of oral SPI-1005 in adults with Meniere's disease. All subjects will undergo baseline audiometric testing and have their severity of sensorineural hearing loss, tinnitus and vertigo determined before the start of a 21-day course of treatment with SPI-1005 or placebo. During treatment with SPI-1005, and 7 days and 28 days following the cessation of SPI-1005, subjects will have their hearing loss, tinnitus and vertigo assessed. Additional testing including electrocochleography will be performed at baseline, at the end of SPI-1005 treatment, and 28 days after the SPI-1005 treatment has stopped. Six outpatient visits will be performed over a 7-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 0 mg SPI-1005 bid po x 21d |
|
| Low dose | Active Comparator | 200 mg SPI-1005 bid po x 21d |
|
| Mid dose | Active Comparator | 400 mg SPI-1005 bid po x 21d |
|
| High dose | Active Comparator | 600 mg SPI-1005 bid po x 21d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPI-1005 | Drug | Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of of Treatment-Emergent Adverse Events | Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures. | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Ebselen Levels of SPI-1005 After 21 Days of Dosing | Trough values | 21 days |
| Plasma Selenium Levels | Plasma selenium levels at 28 days post-treatment |
Not provided
Inclusion Criteria:
Diagnosis of probable or definite Meniere's Disease by AAO-HNS 1995 criteria within 12 months of study enrollment;
Voluntarily consent to participate in the study;
Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:
Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Kil, MD | Sound Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| House Clinic | Los Angeles | California | 90057 | United States | ||
| New York Otology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17030476 | Background | Kil J, Pierce C, Tran H, Gu R, Lynch ED. Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase. Hear Res. 2007 Apr;226(1-2):44-51. doi: 10.1016/j.heares.2006.08.006. Epub 2006 Oct 6. | |
| Background | Lynch E, Kil J. Development of ebselen, a glutathione peroxidase mimic, for the prevention and treatment of noise-induced hearing loss. Semin Hear 2009; 30(1):47-55. | ||
| 33678494 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. |
| FG001 | Low Dose | 200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. |
| FG002 | Mid Dose | 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. |
| FG003 | High Dose | 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. |
| BG001 | Low Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of of Treatment-Emergent Adverse Events | Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures. | Posted | Count of Participants | Participants | 7 weeks |
|
7 weeks
Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Sound Pharmaceuticals, Inc. | 2066342559 | info@soundpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 14, 2016 | Jun 3, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 7, 2017 | Jun 3, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| D034381 | Hearing Loss |
| D014717 | Vertigo |
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D018159 | Endolymphatic Hydrops |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C042986 | ebselen |
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|
| 7 weeks |
| Impact on Sensorineural Hearing Loss | Number of participants demonstrating improvement in Sensorineural Hearing Loss measured using pure tone audiometry. Improvement was defined as a decrease from baseline value by 10 dB or more at one or more low-frequency thresholds (0.25, 0.5, or 1.0 kHz) in at least one ear. | 7 weeks |
| Impact on Speech Discrimination | Number of participants demonstrating improvement in Speech Discrimination measured using the Words in Noise test. Improvement was defined as an increase from baseline value by 10% or more in the total score (0-35, where a higher score is a better outcome) in at least one ear. | 7 weeks |
| Impact on Tinnitus | Number of participants demonstrating improvement in the Tinnitus Functional Index (TFI). Improvement was defined as a decrease from baseline value by 10 points or more in the total score (0-100, where a higher score is a worse outcome). | 7 weeks |
| Impact on Vertigo | Number of participants demonstrating improvement in the Vertigo Symptom Scale - Short Form (VSS). Improvement was defined as a decrease from baseline value by 6 points or more in the total score (0-60, where a higher score is a worse outcome). | 7 weeks |
| New York |
| New York |
| 10028 |
| United States |
| MUSC | Charleston | South Carolina | 29425 | United States |
| Sound Pharmaceuticals, Inc. | Seattle | Washington | 98103 | United States |
| Northwest Ear | Seattle | Washington | 98104 | United States |
| Background |
| Kil J, Harruff EE, Longenecker RJ. Development of ebselen for the treatment of sensorineural hearing loss and tinnitus. Hear Res. 2022 Jan;413:108209. doi: 10.1016/j.heares.2021.108209. Epub 2021 Feb 19. |
| 32483557 | Derived | Garland M, Hryckowian AJ, Tholen M, Bender KO, Van Treuren WW, Loscher S, Sonnenburg JL, Bogyo M. The Clinical Drug Ebselen Attenuates Inflammation and Promotes Microbiome Recovery in Mice after Antibiotic Treatment for CDI. Cell Rep Med. 2020 Apr 21;1(1):100005. doi: 10.1016/j.xcrm.2020.100005. |
| Non-compliance with protocol |
|
200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. |
| BG002 | Mid Dose | 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. |
| BG003 | High Dose | 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Plasma Selenium level | Selenium values of >800 ng/mL are excluded from the analysis. Selenium values of >800 ng/mL were categorized but specific measurements were not obtained. | Mean | Standard Deviation | ng/mL |
|
| OG002 | Mid Dose | 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. |
| OG003 | High Dose | 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. |
|
|
| Secondary | Plasma Ebselen Levels of SPI-1005 After 21 Days of Dosing | Trough values | Blood samples taken from participants assigned to the placebo group were not analyzed since no ebselen was administered. | Posted | Geometric Mean | Standard Deviation | ng/mL | 21 days |
|
|
|
| Secondary | Plasma Selenium Levels | Plasma selenium levels at 28 days post-treatment | Posted | Mean | Standard Deviation | ng/mL | 7 weeks |
|
|
|
| Secondary | Impact on Sensorineural Hearing Loss | Number of participants demonstrating improvement in Sensorineural Hearing Loss measured using pure tone audiometry. Improvement was defined as a decrease from baseline value by 10 dB or more at one or more low-frequency thresholds (0.25, 0.5, or 1.0 kHz) in at least one ear. | Posted | Count of Participants | Participants | 7 weeks |
|
|
|
| Secondary | Impact on Speech Discrimination | Number of participants demonstrating improvement in Speech Discrimination measured using the Words in Noise test. Improvement was defined as an increase from baseline value by 10% or more in the total score (0-35, where a higher score is a better outcome) in at least one ear. | Posted | Count of Participants | Participants | 7 weeks |
|
|
|
| Secondary | Impact on Tinnitus | Number of participants demonstrating improvement in the Tinnitus Functional Index (TFI). Improvement was defined as a decrease from baseline value by 10 points or more in the total score (0-100, where a higher score is a worse outcome). | Posted | Count of Participants | Participants | 7 weeks |
|
|
|
| Secondary | Impact on Vertigo | Number of participants demonstrating improvement in the Vertigo Symptom Scale - Short Form (VSS). Improvement was defined as a decrease from baseline value by 6 points or more in the total score (0-60, where a higher score is a worse outcome). | Posted | Count of Participants | Participants | 7 weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Low Dose | 200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. | 0 | 10 | 0 | 10 | 2 | 10 |
| EG002 | Mid Dose | 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. | 0 | 10 | 0 | 10 | 5 | 10 |
| EG003 | High Dose | 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics. | 0 | 9 | 0 | 9 | 5 | 9 |
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Ophthalmic herpes simplex | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
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| D006311 |
| Hearing Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015837 | Vestibular Diseases |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|