Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment (ASSENT)
|Hearing Loss, Idiopathic Sudden Sensorineural||Drug: AM-111 0.4 mg/ml Drug: AM-111 0.8 mg/ml Other: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment|
- Pure tone average (PTA; average of the hearing threshold of the three contiguous most affected hearing frequencies) [ Time Frame: Day 91 ]Assessment with pure tone audiometry/ Measurement at 8 frequencies/ Final outcome is the absolute improvement in PTA from Day 0 to Day 91
- Word recognition score (WRS) - main secondary [ Time Frame: Day 91 ]Absolute improvement in WRS (80dB) from baseline to Day 91
|Study Start Date:||June 2016|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo gel for intratympanic use
Placebo gel is administered with a single dose into the affected ear after topical anesthesia
Experimental: AM-111 0.4 mg/ml
AM-111 gel for intratympanic use (0.4 mg/ml AM-111)
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
Experimental: AM-111 0.8 mg/ml
AM-111 gel for intratympanic use (0.8 mg/ml AM-111)
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02809118
|Contact: Auris Medical||ear[@]aurismedical.com|
|United States, Florida|
|Please check link to study webpage below for site list||Recruiting|
|Boca Raton, Florida, United States|