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

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

SUBMITTER: Staecker H 

PROVIDER: S-EPMC6553962 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature