Clinical Trial: AM-111 in the Treatment of Acute Inner Ear Hearing Loss

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Auris Medical AG

Current Primary Outcome: Pure tone average (PTA; average of the hearing threshold of three contiguous most affected hearing frequencies in dB) [ Time Frame: Day 28 ]

Assessment with pure tone audiometry/ Measurement at 8 frequencies/ Final outcome is the absolute improvement in PTA from D0 to D28


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Auris Medical, Inc.

Dates:
Date Received: September 23, 2015
Date Started: November 2015
Date Completion: September 2017
Last Updated: January 18, 2017
Last Verified: January 2017