Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
Condition: Hearing Loss, Idiopathic Sudden Sensorineural
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Intervention: AM-111 0.4 mg/ml; AM-111 0.8 mg/ml; Placebo
Intervention description: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia; AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia; Placebo gel is administered with a single dose into the affected ear after topical anesthesia
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Unilateral idiopathic sudden sensorineural hearing loss (ISSNHL) with onset within 72
             hours prior to study treatment;

          2. Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across those 3
             contiguous air conduction audiometric pure tone frequencies that show the highest mean
             hearing loss compared with the unaffected contralateral ear or, in case of history of
             asymmetric hearing, corresponding values from a pre-existing audiogram for the
             affected ear not older than 2 years prior to the ISSNHL incident (defined as "pure
             tone average", PTA);

          3. Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air
             conduction thresholds at the pure tone average frequencies compared with the
             unaffected contralateral ear or, in case of history of asymmetric hearing,
             corresponding values from a preexisting audiogram for the affected ear not older than
             2 years prior to the ISSNHL incident;

          4. Age ≥ 18 years on the day of screening;

        Exclusion Criteria:

          1. Bilateral ISSNHL;

          2. Acute hearing loss from noise trauma, barotrauma or head trauma;

          3. Air-bone gap greater than 20 dB at the average of 3 contiguous test frequencies below
             4 kHz, when the air-bone gap is measurable;

          4. History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic
             hydrops or Menière's disease in either ear;

          5. History of chronic inflammatory or suppurative ear disease or cholesteatoma in the
             affected ear;

          6. Current evidence or history of acoustic neuroma or other retrocochlear damage in the
             affected ear;

          7. History of otosclerosis in the affected ear;

          8. Suspected perilymph fistula or membrane rupture in the affected ear;

          9. Congenital hearing loss;

         10. History of ISSNHL in the past 2 years;

         11. Otitis media or otitis externa that is ongoing or ended within 7 days prior to study
             treatment;