Clinical Trial: A Phase 2b Study of SPI-1005 to Reduce the Incidence, Severity, and Duration of Acute Noise Induced Hearing Loss

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 2b, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of SPI-1005 to Reduce the Incidence, Severity and Duration of Acute Noise Ind

Brief Summary: SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.

Detailed Summary: Randomized, double-blind, placebo-controlled, safety and efficacy study of oral SPI-1005 in adults with Noise Induced Hearing Loss (NIHL). All recruited subjects will have their severity of NIHL determined before the start of SPI-1005 treatment using otoscopy, tympanometry and audiometry. Subjects with >15 and </= 40 decibel (dB) NIHL will be enrolled and randomized to either placebo or SPI-1005. Patients will be dosed with either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL. Patients will have audiometry and Words In Noise Testing (WINT) before and immediately after a calibrated sound challenge (CSC). The CSC involves listening to 4 hours of pre-recorded music (100 dBA SPL) through insert earphones. The CSC induces a slight acute NIHL. Follow-up audiometry and WINT will be performed at 1 and 7 days post-CSC. A total of four clinic visits will be required over 10-14 days.
Sponsor: Sound Pharmaceuticals, Incorporated

Current Primary Outcome: Reduction in the Incidence of a Significant Threshold Shift [ Time Frame: Within 1 day ]

Post Controlled Sound Challenge pure tone audiometry will be compared with baseline


Original Primary Outcome: Reduction in the Incidence of a Significant Threshold Shift [ Time Frame: Within 1 day ]

Post-CSC pure tone audiometry will be compared with baseline


Current Secondary Outcome: Improvement in word recognition score [ Time Frame: Within 1 day ]

Post Controlled Sound Challenge Words in Noise Test score will be compared with baseline


Original Secondary Outcome: Improvement in word recognition score [ Time Frame: Within 1 day ]

Post-CSC Words in Noise Test scores will be compared with baseline


Information By: Sound Pharmaceuticals, Incorporated

Dates:
Date Received: May 18, 2016
Date Started: September 2016
Date Completion: September 2017
Last Updated: May 31, 2016
Last Verified: May 2016