NCT02809118

Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Auris Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).

Detailed description

This is a Phase III, randomized, double-blind, placebo-controlled, parallel group, multi-center, efficacy and safety trial of AM-111 in the treatment of subjects suffering from severe to profound idiopathic sudden sensorineural hearing loss. The active pharmaceutical ingredient of AM-111 is a 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. The study consists of one treatment visit and a follow-up period until day 91. Study participants will receive, after topical anesthesia of the tympanic membrane, AM-111 0.4 mg/mL or 0.8 mg/mL or placebo, administered into the affected ear. Following the administration, subjects will rest in a supine or reclined position for 30 minutes. Study participants will have the option for a course of oral corticosteroids.

Conditions

• Hearing Loss, Idiopathic Sudden Sensorineural

Interventions

Type	Name	Description
DRUG	AM-111 0.4 mg/ml	AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
DRUG	AM-111 0.8 mg/ml	AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
OTHER	Placebo	Placebo gel is administered with a single dose into the affected ear after topical anesthesia

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2016-06-22
• Last updated: 2020-08-07
• Results posted: 2020-08-07

Locations

51 sites across 3 countries: United States, Canada, South Korea