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

NCT02809118 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-08-07

Study results available
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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).

Conditions

  • Hearing Loss, Idiopathic Sudden Sensorineural

Interventions

DRUG

AM-111 0.4 mg/ml

AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia

DRUG

AM-111 0.8 mg/ml

AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia

OTHER

Placebo

Placebo gel is administered with a single dose into the affected ear after topical anesthesia

Sponsors & Collaborators

  • Auris Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Meier · Auris Medical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States
  • Canada
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02809118 on ClinicalTrials.gov