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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.

Tracking Information
First Submitted Date  ICMJE June 20, 2016
First Posted Date  ICMJE June 22, 2016
Results First Submitted Date  ICMJE April 24, 2020
Results First Posted Date  ICMJE August 7, 2020
Last Update Posted Date August 7, 2020
Study Start Date  ICMJE June 2016
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2016)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2016)
Word Recognition Score (WRS) - Main Secondary [ Time Frame: Day 91 ]
Absolute improvement in WRS (80dB) from baseline to Day 91
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
Official Title  ICMJE Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hearing Loss, Idiopathic Sudden Sensorineural
Intervention  ICMJE
  • 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
  • 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
  • Other: Placebo
    Placebo gel is administered with a single dose into the affected ear after topical anesthesia
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo gel for intratympanic use
    Intervention: Other: Placebo
  • Experimental: AM-111 0.4 mg/ml
    AM-111 gel for intratympanic use (0.4 mg/ml AM-111)
    Intervention: Drug: AM-111 0.4 mg/ml
  • Experimental: AM-111 0.8 mg/ml
    AM-111 gel for intratympanic use (0.8 mg/ml AM-111)
    Intervention: Drug: AM-111 0.8 mg/ml
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 8, 2017)
56
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2016)
300
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02809118
Other Study ID Numbers  ICMJE AM-111-CL-15-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Auris Medical, Inc.
Study Sponsor  ICMJE Auris Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thomas Meier Auris Medical, Inc.
PRS Account Auris Medical, Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP