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AM-111

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

August 7, 2020

https://clinicaltrials.gov/ct2/show/NCT02809118?type=Intr&cond=Hearing+Loss&lupd_s=07%2F24%2F2020&lupd_d=14&sort=nwst

Condition :   Hearing Loss, Idiopathic Sudden Sensorineural

Interventions :   Drug: AM-111 0.4 mg/ml;   Drug: AM-111 0.8 mg/ml;   Other: Placebo

Sponsor :   Auris Medical, Inc.

Terminated

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

NCT02809118

Wed, 22 Jun 2016 12:00:00 EDT

Last Update Posted: 08/07/20 06:52AM

Efficacy and Safety of AM-111 in the Treatment of Acute Unilateral Sudden Deafness

May 15, 2019

https://journals.lww.com/otology-neurotology/fulltext/2019/06000/Efficacy_and_Safety_of_AM_111_in_the_Treatment_of.6.aspx

https://www.ncbi.nlm.nih.gov/pubmed/31083077?dopt=Abstract

Related Articles

Efficacy and Safety of AM-111 in the Treatment of Acute Unilateral Sudden Deafness-A Double-blind, Randomized, Placebo-controlled Phase 3 Study.

Otol Neurotol. 2019 Jun;40(5):584-594

Authors: Staecker H, Jokovic G, Karpishchenko S, Kienle-Gogolok A, Krzyzaniak A, Lin CD, Navratil P, Tzvetkov V, Wright N, Meyer T

Abstract

OBJECTIVE: To confirm the efficacy and safety of AM-111 (brimapitide), a cell-penetrating c-Jun N-terminal Kinase (JNK) inhibitor, in patients suffering from severe to profound acute unilateral idiopathic sudden sensorineural hearing loss (ISSNHL).

STUDY DESIGN: Prospective, double-blind, randomized, placebo-controlled phase 3 study with follow-up visits on Days 3, 7, 28, and 91.

SETTING: Fifty-one European and Asian sites (tertiary referral centers, private ENT practices).

PATIENTS: Two hundred fifty-six patients aged 18 to 65 years presenting within 72 hours following ISSNHL onset with mean hearing loss ≥ 40 dB and mean threshold ≥ 60 dB at the 3 worst affected contiguous test frequencies.

INTERVENTIONS: Single-dose intratympanic injection of AM-111 (0.4 or 0.8 mg/ml) or placebo; oral prednisolone as reserve therapy if hearing improvement < 10 dB at Day 7. MAIN OUTCOME MEASURES: Hearing improvement to Day 28 was the primary efficacy endpoint; complete hearing recovery, frequency of reserve therapy used, complete tinnitus remission, improvement in word recognition were secondary endpoints. Safety was evaluated by the frequency of clinically relevant hearing deterioration and adverse events. RESULTS: While the primary efficacy endpoint was not met in the overall study population, post-hoc analysis showed a clinically relevant and nominally significant treatment effect for AM-111 0.4 mg/ml in patients with profound ISSNHL. The study drug and the administration procedure were well tolerated. CONCLUSIONS: AM-111 provides effective otoprotection in case of profound ISSNHL. Activation of the JNK stress kinase, AM-111's pharmacologic target, seems to set in only following pronounced acute cochlear injury associated with large hearing threshold shifts. PMID: 31083077 [PubMed - in process]

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