Meniere's Disease Clinical Trial
Official title:
Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease
Verified date | March 2021 |
Source | Sound Pharmaceuticals, Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 70 Years |
Eligibility | 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: - Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or - IUD in place for at least 3 months prior to study through study completion; or - Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or - Stable hormonal contraceptive for at least 3 months prior to study through study completion; or - Surgical sterilization (vasectomy) of partner at least 6 months prior to study. - 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: - Current use or within 90 days prior to study of ototoxic medications such as aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide); - History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma; - History of middle ear or inner ear surgery; - Current conductive hearing loss or middle ear effusion; - Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease; - History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen; - Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes; - Participation in another investigational drug or device study within 90 days prior to study enrollment; - Female patients who are pregnant or breastfeeding. |
Country | Name | City | State |
---|---|---|---|
United States | MUSC | Charleston | South Carolina |
United States | House Clinic | Los Angeles | California |
United States | New York Otology | New York | New York |
United States | Northwest Ear | Seattle | Washington |
United States | Sound Pharmaceuticals, Inc. | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Sound Pharmaceuticals, Incorporated |
United States,
Kil J, Harruff EE, Longenecker RJ. Development of ebselen for the treatment of sensorineural hearing loss and tinnitus. Hear Res. 2021 Feb 19:108209. doi: 10.1016/j.heares.2021.108209. [Epub ahead of print] — View Citation
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. Epub 2006 Oct 6. — View Citation
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures. | Incidence of of Treatment-Emergent Adverse Events | 7 weeks | |
Secondary | Plasma Ebselen levels of SPI-1005 before, during, and after 21 days of dosing | Evaluation of potential accumulation of study drug | 7 weeks | |
Secondary | Plasma Selenium levels before, during, and after 21 days of dosing | Evaluation of potential changes in plasma selenium levels | 7 weeks | |
Secondary | Impact on Sensorineural Hearing Loss | Pure Tone Audiometry | 7 weeks | |
Secondary | Impact on Speech Discrimination | Words in Noise Test | 7 weeks | |
Secondary | Impact on Tinnitus | Questionnaire | 7 weeks | |
Secondary | Impact on Vertigo | Questionnaire | 7 weeks | |
Secondary | Pharmacodynamic response | Electrocochleography | 7 weeks |
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