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

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ClinicalTrials.gov Identifier: NCT02809118
Recruitment Status : Terminated (Availability of relevant new efficacy data from another study)
First Posted : June 22, 2016
Results First Posted : August 7, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc.

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).

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
Study Start Date : June 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018


Arm Intervention/treatment
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
Other Name: Brimapitide

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
Other Name: Brimapitide




Primary Outcome Measures :
  1. Pure Tone Average (PTA) [ Time Frame: Day 0 and Day 91: The study was prematurely terminated. ]
    Measurement of the recovery of hearing between Day 0 (before treatment) and Day 91, i.e. change in pure tone audiometry between Day 0 and Day 91. The study was prematurely terminated. It was pre-specified not to complete analyses due to premature termination. Not all data planned were collected. No meaningful efficacy analysis could be performed on the data.


Secondary Outcome Measures :
  1. Word Recognition Score (WRS) - Main Secondary [ Time Frame: Day 0 and Day 91: The study was prematurely terminated. ]
    Change in WRS from Day 0 to Day 91. The WRS was determined with country-/language-specific word lists. At least 20 mono- or disyllabic words were presented in random order. After each word was presented to the subject, the subject was asked to repeat it, and to guess it, if he/she was not sure of the word. The study was prematurely terminated. It was pre-specified not to complete analyses due to premature termination. Not all data planned were collected. No meaningful efficacy analysis could be performed on the data.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809118


Locations
Show Show 51 study locations
Sponsors and Collaborators
Auris Medical, Inc.
Investigators
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Study Director: Thomas Meier Auris Medical, Inc.
  Study Documents (Full-Text)

Documents provided by Auris Medical, Inc.:
Study Protocol  [PDF] May 24, 2017
Statistical Analysis Plan  [PDF] February 6, 2018

Additional Information:
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Responsible Party: Auris Medical, Inc.
ClinicalTrials.gov Identifier: NCT02809118    
Other Study ID Numbers: AM-111-CL-15-01
First Posted: June 22, 2016    Key Record Dates
Results First Posted: August 7, 2020
Last Update Posted: August 7, 2020
Last Verified: June 2020
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:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases