Study to Evaluate SPI-1005 in Adults With Meniere's Disease
- Registration Number
- NCT02603081
- Lead Sponsor
- Sound Pharmaceuticals, Incorporated
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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Diagnosis of probable or definite Meniere's Disease by AAO-HNS 1995 criteria within 12 months of study enrollment;
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Voluntarily consent to participate in the study;
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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.
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose SPI-1005 200 mg SPI-1005 bid po x 21d High dose SPI-1005 600 mg SPI-1005 bid po x 21d Placebo SPI-1005 0 mg SPI-1005 bid po x 21d Mid dose SPI-1005 400 mg SPI-1005 bid po x 21d
- Primary Outcome Measures
Name Time Method Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures. 7 weeks Incidence of of Treatment-Emergent Adverse Events
- Secondary Outcome Measures
Name Time Method Impact on Tinnitus 7 weeks Questionnaire
Impact on Vertigo 7 weeks Questionnaire
Plasma Ebselen levels of SPI-1005 before, during, and after 21 days of dosing 7 weeks Evaluation of potential accumulation of study drug
Plasma Selenium levels before, during, and after 21 days of dosing 7 weeks Evaluation of potential changes in plasma selenium levels
Impact on Sensorineural Hearing Loss 7 weeks Pure Tone Audiometry
Impact on Speech Discrimination 7 weeks Words in Noise Test
Pharmacodynamic response 7 weeks Electrocochleography
Trial Locations
- Locations (5)
MUSC
🇺🇸Charleston, South Carolina, United States
New York Otology
🇺🇸New York, New York, United States
House Clinic
🇺🇸Los Angeles, California, United States
Sound Pharmaceuticals, Inc.
🇺🇸Seattle, Washington, United States
Northwest Ear
🇺🇸Seattle, Washington, United States