Hearing Loss, Idiopathic Sudden Sensorineural Clinical Trial
Official title:
Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
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).
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.
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