Conditions: Hearing Loss, Idiopathic Sudden Sensorineural
Keywords: Deafness Hearing Loss Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Sensation Disorders Signs and Symptoms Hearing and Speech Impairment Hearing Loss, Unilateral
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: no

Brief summary:
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).

Detailed description:
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.

Arms:
arm 1: Placebo gel for intratympanic use arm 2: AM-111 gel for intratympanic use (0.4 mg/ml AM-111) arm 3: AM-111 gel for intratympanic use (0.8 mg/ml AM-111)

Interventions: intervention 1: AM-111 0.4 mg/ml intervention 2: AM-111 0.8 mg/ml intervention 3: Placebo
Intervention descriptions: intervention 1: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia intervention 2: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia intervention 3: Placebo gel is administered with a single dose into the affected ear after topical anesthesia

Protocol document:
Prot_000.pdf: 

















































































































































































SAP_001.pdf: