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The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere's disease with active symptoms within three months preceding study enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPI-1005 400 mg BID | Experimental | Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup |
|
| Placebo | Placebo Comparator | Oral administration of matching placebo BID for 28 days, with 84-day followup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ebselen | Drug | Glutathione peroxidase mimetic |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Safety and tolerability assessed based on comparison of adverse events vs. placebo | 84 days |
| Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry | Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry | 84 days |
| Change in Words-in-Noise Test Score | Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test (WIN Score Improvement from Baseline >=4 words) | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tinnitus Severity | Tinnitus Functional Index (0-100) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome. | 84 days |
| Change in Tinnitus Loudness |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| University of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33678494 | 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. | |
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SPI-1005 400 mg BID | Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup Ebselen: Glutathione peroxidase mimetic |
| FG001 | Placebo | Oral administration of matching placebo BID for 28 days, with 84-day followup Placebo: Matching placebo containing excipients |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SPI-1005 400 mg BID | Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup Ebselen: Glutathione peroxidase mimetic |
| BG001 | Placebo | Oral administration of matching placebo BID for 28 days, with 84-day followup Placebo: Matching placebo containing excipients |
| 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 Treatment-Emergent Adverse Events | Safety and tolerability assessed based on comparison of adverse events vs. placebo | Posted | Count of Participants | Participants | 84 days |
|
SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
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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 | SPI-1005 400 mg BID | Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup Ebselen: Glutathione peroxidase mimetic |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (25.0) | 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 | Apr 8, 2021 | May 31, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2024 | May 31, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| D034381 | Hearing Loss |
| D014012 | Tinnitus |
| D014717 | Vertigo |
| D004244 | Dizziness |
| 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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| Placebo | Drug | Matching placebo containing excipients |
|
Tinnitus Functional Index Question #2 -- How Strong or Loud was your Tinnitus? (0-10) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome.
| 84 days |
| Change in Vertigo Severity | Vertigo Symptom Scale (0-60) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome. | 84 days |
| Change in Aural Fullness | Aural Fullness Scale (0-10) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome. | 84 days |
| Change in Dizziness | Dizziness Handicap Inventory (0-100) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome. | 84 days |
| Los Angeles |
| California |
| 90033 |
| United States |
| House Clinic | Los Angeles | California | 90057 | United States |
| Sacramento Ear, Nose, & Throat | Roseville | California | 95661 | United States |
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
| ENT and Allergy Associates of Florida | Boca Raton | Florida | 33487 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Advanced ENT & Allergy | Louisville | Kentucky | 40207 | United States |
| Piedmont Ear, Nose & Throat Associates | Winston-Salem | North Carolina | 27103 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19144 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| 28716314 | Background | Kil J, Lobarinas E, Spankovich C, Griffiths SK, Antonelli PJ, Lynch ED, Le Prell CG. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017 Sep 2;390(10098):969-979. doi: 10.1016/S0140-6736(17)31791-9. Epub 2017 Jul 14. |
| Protocol Violation |
|
| BG002 | 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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry | Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry | Posted | Count of Participants | Participants | 84 days |
|
|
|
| Primary | Change in Words-in-Noise Test Score | Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test (WIN Score Improvement from Baseline >=4 words) | Posted | Count of Participants | Participants | 84 days |
|
|
|
| Secondary | Change in Tinnitus Severity | Tinnitus Functional Index (0-100) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome. | Posted | Mean | Standard Deviation | score | 84 days |
|
|
|
| Secondary | Change in Tinnitus Loudness | Tinnitus Functional Index Question #2 -- How Strong or Loud was your Tinnitus? (0-10) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome. | Posted | Mean | Standard Deviation | score | 84 days |
|
|
|
| Secondary | Change in Vertigo Severity | Vertigo Symptom Scale (0-60) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome. | Posted | Mean | Standard Deviation | score | 84 days |
|
|
|
| Secondary | Change in Aural Fullness | Aural Fullness Scale (0-10) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 84 days |
|
|
|
| Secondary | Change in Dizziness | Dizziness Handicap Inventory (0-100) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome. | Posted | Mean | Standard Deviation | score | 84 days |
|
|
|
| 0 |
| 112 |
| 2 |
| 112 |
| 25 |
| 112 |
| EG001 | Placebo | Oral administration of matching placebo BID for 28 days, with 84-day followup Placebo: Matching placebo containing excipients | 0 | 108 | 0 | 108 | 19 | 108 |
| EG002 | Open Label Extension: SPI-1005 400 mg BID | Oral administration of SPI-1005 400 mg BID for up to 360 days Ebselen: Glutathione peroxidase mimetic | 0 | 197 | 4 | 197 | 90 | 197 |
| Diverticulitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA (25.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
|
The PI will not, during or subsequent to the term of the Clinical Trial Agreement, use Confidential Information for any purpose whatsoever other than the performance of the Services, and will not disclose Confidential Information to any third party. Confidential Information will remain the sole property of Sponsor, as applicable.
| 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 |