Study to Evaluate SPI-1005 in Adults With Meniere's Disease

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

• NCT number: NCT02603081
• Study type: Interventional
• Source: Sound Pharmaceuticals, Incorporated
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2015
• Completion date: August 2017