Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment (ASSENT)
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|ClinicalTrials.gov Identifier: NCT02809118|
Recruitment Status : Terminated (Availability of relevant new efficacy data from another study)
First Posted : June 22, 2016
Results First Posted : August 7, 2020
Last Update Posted : August 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss, Idiopathic Sudden Sensorineural||Drug: AM-111 0.4 mg/ml Drug: AM-111 0.8 mg/ml Other: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||February 2018|
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
Other Name: Brimapitide
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
Other Name: Brimapitide
- Pure Tone Average (PTA) [ Time Frame: Day 0 and Day 91: The study was prematurely terminated. ]Measurement of the recovery of hearing between Day 0 (before treatment) and Day 91, i.e. change in pure tone audiometry between Day 0 and Day 91. The study was prematurely terminated. It was pre-specified not to complete analyses due to premature termination. Not all data planned were collected. No meaningful efficacy analysis could be performed on the data.
- Word Recognition Score (WRS) - Main Secondary [ Time Frame: Day 0 and Day 91: The study was prematurely terminated. ]Change in WRS from Day 0 to Day 91. The WRS was determined with country-/language-specific word lists. At least 20 mono- or disyllabic words were presented in random order. After each word was presented to the subject, the subject was asked to repeat it, and to guess it, if he/she was not sure of the word. The study was prematurely terminated. It was pre-specified not to complete analyses due to premature termination. Not all data planned were collected. No meaningful efficacy analysis could be performed on the data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809118
|Study Director:||Thomas Meier||Auris Medical, Inc.|