NCT02561091

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Auris Medical AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
OTHER	Placebo
DRUG	AM-111 0.4 mg/ml
DRUG	AM-111 0.8 mg/ml

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2015-09-25
• Last updated: 2023-09-14

Locations

1 site across 1 country: Bulgaria