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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hearing Loss, Idiopathic Sudden Sensorineural
Interventions Drug: AM-111 0.4 mg/ml
Drug: AM-111 0.8 mg/ml
Other: Placebo
Enrollment 56
Recruitment Details

The study was prematurely discontinued while recruitment was still low (56 out of the planned 300 subjects).

Recruitment started on 16 June 2016. On 28 November 2017, recruitment was stopped. This study was conducted in USA, Canada and South Korea.

Pre-assignment Details In subjects assessed within the first 24 hours from Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL) onset, mean hearing threshold had to be confirmed by a second measure that was conducted, at the earliest, 24 hours after the onset of ISSNHL.
Arm/Group Title Placebo AM-111 0.4 mg/ml AM-111 0.8 mg/ml
Hide Arm/Group Description

Placebo gel for intratympanic use

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

AM-111 gel for intratympanic use (0.4 mg/ml AM-111)

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

AM-111 gel for intratympanic use (0.8 mg/ml AM-111)

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

Period Title: Overall Study
Started 18 19 19
Completed 18 18 18
Not Completed 0 1 1
Reason Not Completed
Withdrawal by Subject             0             1             1
Arm/Group Title Placebo AM-111 0.4 mg/ml AM-111 0.8 mg/ml Total
Hide Arm/Group Description

Placebo gel for intratympanic use

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

AM-111 gel for intratympanic use (0.4 mg/ml AM-111)

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

AM-111 gel for intratympanic use (0.8 mg/ml AM-111)

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

Total of all reporting groups
Overall Number of Baseline Participants 18 19 19 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 18 participants 19 participants 19 participants 56 participants
57.7  (15.25) 57.0  (15.13) 54.6  (14.36) 55.6  (14.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 19 participants 56 participants
Female
12
  66.7%
7
  36.8%
8
  42.1%
27
  48.2%
Male
6
  33.3%
12
  63.2%
11
  57.9%
29
  51.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 19 participants 56 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
12
  66.7%
8
  42.1%
11
  57.9%
31
  55.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   5.3%
1
   5.3%
2
   3.6%
White
6
  33.3%
10
  52.6%
6
  31.6%
22
  39.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   5.3%
1
   1.8%
1.Primary Outcome
Title Pure Tone Average (PTA)
Hide Description 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.
Time Frame Day 0 and Day 91: The study was prematurely terminated.
Hide Outcome Measure Data
Hide Analysis Population Description
The study was prematurely terminated. No meaningful efficacy analysis could be performed on the data.
Arm/Group Title Placebo AM-111 0.4 mg/ml AM-111 0.8 mg/ml
Hide Arm/Group Description:

Placebo gel for intratympanic use

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

AM-111 gel for intratympanic use (0.4 mg/ml AM-111)

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

AM-111 gel for intratympanic use (0.8 mg/ml AM-111)

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

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Word Recognition Score (WRS) - Main Secondary
Hide Description 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.
Time Frame Day 0 and Day 91: The study was prematurely terminated.
Hide Outcome Measure Data
Hide Analysis Population Description
The study was prematurely terminated. No meaningful efficacy analysis could be performed on the data.
Arm/Group Title Placebo AM-111 0.4 mg/ml AM-111 0.8 mg/ml
Hide Arm/Group Description:

Placebo gel for intratympanic use

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

AM-111 gel for intratympanic use (0.4 mg/ml AM-111)

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

AM-111 gel for intratympanic use (0.8 mg/ml AM-111)

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

Overall Number of Participants Analyzed 0 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Percentage of correct word responses
0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame For each participant, adverse event data were collected from day 0 to day 91(±7).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo AM-111 0.4 mg/ml AM-111 0.8 mg/ml
Hide Arm/Group Description

Placebo gel for intratympanic use

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

AM-111 gel for intratympanic use (0.4 mg/ml AM-111)

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

AM-111 gel for intratympanic use (0.8 mg/ml AM-111)

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

All-Cause Mortality
Placebo AM-111 0.4 mg/ml AM-111 0.8 mg/ml
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/19 (0.00%)      0/19 (0.00%)    
Hide Serious Adverse Events
Placebo AM-111 0.4 mg/ml AM-111 0.8 mg/ml
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      1/19 (5.26%)      0/19 (0.00%)    
Ear and labyrinth disorders       
Vertigo * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
General disorders       
Chest pain * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Infections and infestations       
Sepsis * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
1
Term from vocabulary, MedDRA Version 19.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo AM-111 0.4 mg/ml AM-111 0.8 mg/ml
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/18 (44.44%)      11/19 (57.89%)      10/19 (52.63%)    
Blood and lymphatic system disorders       
Mastocytosis * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Splenomegaly * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Cardiac disorders       
Palpitations * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Congenital, familial and genetic disorders       
Colour blindness * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Ear and labyrinth disorders       
Tinnitus  1  1/18 (5.56%)  1 2/19 (10.53%)  2 1/19 (5.26%)  1
Vertigo * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Vertigo positional * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 1/19 (5.26%)  1
Ear discomfort * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Ear pruritus * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Eustachian tube disfunction * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Otorrhoea * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Tympanic membrane perforation  1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Eye disorders       
Conjunctival hyperaemia * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Eye pain * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Ocular hyperaemia * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Vision blurred * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Gastrointestinal disorders       
Nausea * 1  2/18 (11.11%)  2 1/19 (5.26%)  1 0/19 (0.00%)  0
Gastrooesophageal reflux disease * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Irritable bowel syndrome * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Vomiting * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Dyspesia * 1  2/18 (11.11%)  2 0/19 (0.00%)  0 1/19 (5.26%)  1
General disorders       
Asthenia * 1  2/18 (11.11%)  2 1/19 (5.26%)  1 0/19 (0.00%)  0
Chest pain * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Facial pain * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Feeling hot * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Malaise * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Oedema peripheral * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Pain * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Pyrexia * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Thirst * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Infections and infestations       
Nasopharyngitis * 1  1/18 (5.56%)  1 1/19 (5.26%)  1 0/19 (0.00%)  0
Urinary tract infection * 1  1/18 (5.56%)  1 1/19 (5.26%)  1 0/19 (0.00%)  0
Acute sinusitis * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Hepatitis * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Hordeolum * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Pneumonia * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Upper respiratory tract infection * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Pharyngitis * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Investigations       
Blood glucose increased  1  0/18 (0.00%)  0 1/19 (5.26%)  1 1/19 (5.26%)  1
Alanine aminotransferase increased  1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Aspartate aminotransferase increased  1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Metabolism and nutrition disorders       
Decreased appetite * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Diabetes mellitus * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Hyperglycaemia * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Fasciitis * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Muscle spasms * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Muscoloskeletal stiffness * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Temporomandibular joint syndrome * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Myalgia * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Meningioma * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Nervous system disorders       
Dizziness * 1  2/18 (11.11%)  2 2/19 (10.53%)  2 1/19 (5.26%)  1
Headache * 1  1/18 (5.56%)  1 1/19 (5.26%)  1 3/19 (15.79%)  3
Hypoaesthesia * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 1/19 (5.26%)  1
Nystagmus  1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Syncope * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Dyspesia * 1  2/18 (11.11%)  2 0/19 (0.00%)  0 1/19 (5.26%)  1
Paraesthesia * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Psychiatric disorders       
Depressed mood * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Depression * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Emotional disorder * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Insomnia * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain * 1  1/18 (5.56%)  1 1/19 (5.26%)  1 1/19 (5.26%)  1
Cough * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 1/19 (5.26%)  1
Throat irritation * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pruritus * 1  1/18 (5.56%)  1 1/19 (5.26%)  1 1/19 (5.26%)  1
Acne * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Dermatitis * 1  0/18 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0
Dermatitis acneiform * 1  0/18 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1
Pruritus generalised * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Vascular disorders       
Aortic dilation * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
Hot flush * 1  1/18 (5.56%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0
1
Term from vocabulary, MedDRA Version 19.0
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: RAM
Organization: Auris Medical
Phone: 0041 61 201 13 ext 50
EMail: ra@aurismedical.com
Layout table for additonal information
Responsible Party: Auris Medical, Inc.
ClinicalTrials.gov Identifier: NCT02809118    
Other Study ID Numbers: AM-111-CL-15-01
First Submitted: June 20, 2016
First Posted: June 22, 2016
Results First Submitted: April 24, 2020
Results First Posted: August 7, 2020
Last Update Posted: August 7, 2020