Clinical Trial: Study to Evaluate SPI-1005 in Adults With Meniere's Disease
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease
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 Summary: 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.
Sponsor: Sound Pharmaceuticals, Incorporated
Current Primary Outcome: Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures. [ Time Frame: 7 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Plasma Ebselen levels of SPI-1005 before, during, and after 21 days of dosing [ Time Frame: 7 weeks ]Evaluation of potential accumulation of study drug
- Plasma Selenium levels before, during, and after 21 days of dosing [ Time Frame: 7 weeks ]Evaluation of potential changes in plasma selenium levels
- Impact on Sensorineural Hearing Loss [ Time Frame: 7 weeks ]Pure Tone Audiometry
- Impact on Speech Discrimination [ Time Frame: 7 weeks ]Words in Noise Test
- Impact on Tinnitus [ Time Frame: 7 weeks ]Questionnaire
- Impact on Vertigo [ Time Frame: 7 weeks ]Questionnaire
- Pharmacodynamic response [ Time Frame: 7 weeks ]Electrocochleography
Original Secondary Outcome: Same as current
Information By: Sound Pharmaceuticals, Incorporated
Dates:
Date Received: November 2, 2015
Date Started: December 2015
Date Completion: December 2016
Last Updated: June 9, 2016
Last Verified: June 2016