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AM-111 in the Treatment of Acute Inner Ear Hearing Loss — HEALOS  

Hearing Loss Clinical Trial

Official title:
Efficacy and Safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss

Clinical Trial Summary

The purpose of this research study is to test the effectiveness and safety of the study drug, AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the cause is unknown.

Clinical Trial Description

This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of intratympanic AM-111 injections in the treatment of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL). The active pharmaceutical ingredient of AM-111 is the JNK inhibitor (D-JNKI-1), a synthetic peptide consisting of 31 D-amino acids, which acts as a c-Jun N-terminal kinase (JNK) ligand. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02561091
Study type Interventional
Source Auris Medical, Inc.
Contact
Status Completed
Phase Phase 3
Start date November 2015
Completion date September 2017
View Details
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