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:
Auris Medical, Inc.
Information provided by (Responsible Party):
Auris Medical, Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
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.
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Nonsyndromic hearing loss
MedlinePlus related topics:
Hearing Disorders and Deafness
| 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 :
- 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 :
- 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.
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Unilateral idiopathic sudden sensorineural hearing loss (ISSNHL) with onset within 72 hours prior to study treatment;
- 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);
- 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;
- Age ≥ 18 years on the day of screening;
Exclusion Criteria:
- Bilateral ISSNHL;
- Acute hearing loss from noise trauma, barotrauma or head trauma;
- 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;
- History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in either ear;
- History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
- Current evidence or history of acoustic neuroma or other retrocochlear damage in the affected ear;
- History of otosclerosis in the affected ear;
- Suspected perilymph fistula or membrane rupture in the affected ear;
- Congenital hearing loss;
- History of ISSNHL in the past 2 years;
- 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 51 study locations
Sponsors and Collaborators
Auris Medical, Inc.
Investigators
| Study Director: | Thomas Meier | Auris Medical, Inc. |
Study Documents (Full-Text)
Documents provided by Auris Medical, Inc.:
Documents provided by Auris Medical, Inc.:
Study Protocol [PDF] May 24, 2017
Statistical Analysis Plan [PDF] February 6, 2018
Additional Information:
| 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:
|
Hearing Loss Deafness Hearing Loss, Sensorineural Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |