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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Auris Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc.
ClinicalTrials.gov Identifier:
NCT02809118
First received: June 20, 2016
Last updated: January 18, 2017
Last verified: January 2017
  Purpose
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).

Condition Intervention Phase
Hearing Loss, Idiopathic Sudden Sensorineural Drug: AM-111 0.4 mg/ml Drug: AM-111 0.8 mg/ml Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment

Resource links provided by NLM:


Further study details as provided by Auris Medical, Inc.:

Primary Outcome Measures:
  • Pure tone average (PTA; average of the hearing threshold of the three contiguous most affected hearing frequencies) [ Time Frame: Day 91 ]
    Assessment with pure tone audiometry/ Measurement at 8 frequencies/ Final outcome is the absolute improvement in PTA from Day 0 to Day 91


Secondary Outcome Measures:
  • Word recognition score (WRS) - main secondary [ Time Frame: Day 91 ]
    Absolute improvement in WRS (80dB) from baseline to Day 91


Estimated Enrollment: 300
Study Start Date: June 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo gel for intratympanic use
Other: Placebo
Placebo gel is administered with a single dose into the affected ear after topical anesthesia
Experimental: AM-111 0.4 mg/ml
AM-111 gel for intratympanic use (0.4 mg/ml AM-111)
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
Experimental: AM-111 0.8 mg/ml
AM-111 gel for intratympanic use (0.8 mg/ml AM-111)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02809118

Contacts
Contact: Auris Medical ear[@]aurismedical.com

Locations
United States, Florida
Please check link to study webpage below for site list Recruiting
Boca Raton, Florida, United States
Sponsors and Collaborators
Auris Medical, Inc.
  More Information

Additional Information:
Responsible Party: Auris Medical, Inc.
ClinicalTrials.gov Identifier: NCT02809118     History of Changes
Other Study ID Numbers: AM-111-CL-15-01
Study First Received: June 20, 2016
Last Updated: January 18, 2017

Keywords provided by Auris Medical, Inc.:
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

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 26, 2017