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Study of the safety of open-label SPI-1005 400 mg BID treatment in adults with Meniere's Disease (MD) for 6 or 12 months to support chronic or chronic intermittent use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental | Oral administration of SPI-1005 400 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ebselen | Drug | Glutathione peroxidase mimetic |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Safety and tolerability assessed based on adverse events | 180 and 360 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The House Institute | Recruiting | Los Angeles | California | 90057 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 17030476 |
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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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Open Label
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| ENT and Allergy Associates of Florida | Recruiting | Boynton Beach | Florida | 33471 | United States |
|
| ENT and Allergy Associates of Florida | Recruiting | Delray Beach | Florida | 33484 | United States |
|
| Northwell Health | Recruiting | New Hyde Park | New York | 11042 | United States |
|
| ENT and Allergy Associates, LLP | Recruiting | New York | New York | 10017 | United States |
|
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| University of Texas Southwestern | Recruiting | Dallas | Texas | 75390 | United States |
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| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| 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. |
| 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. |
| 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 |