NCT02561091

Brief Summary

The purpose of this research study is to test the effectiveness and safety of the study drug, AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the cause is unknown.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

September 23, 2015

Last Update Submit

September 13, 2023

Conditions

Hearing Loss

Keywords

DeafnessHearing Loss, SensorineuralEar DiseasesHearing DisordersOtorhinolaryngologic DiseasesSensation DisordersSigns and SymptomsHearing and Speech impairmentHearing Loss, Unilateral

Outcome Measures

Primary Outcomes (1)

  • Pure tone average (PTA; average of the hearing threshold of three contiguous most affected hearing frequencies in dB)

    Assessment with pure tone audiometry/ Measurement at 8 frequencies/ Final outcome is the absolute improvement in PTA from D0 to D28

    Day 28

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo gel for intratympanic use

Other: Placebo

AM-111 0.4 mg/ml

EXPERIMENTAL

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

Drug: AM-111 0.4 mg/ml

AM-111 0.8 mg/ml

EXPERIMENTAL

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

Drug: AM-111 0.8 mg/ml

Interventions

PlaceboOTHER
Placebo
AM-111 0.4 mg/mlDRUG
AM-111 0.4 mg/ml
AM-111 0.8 mg/mlDRUG
AM-111 0.8 mg/ml

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral ISSNHL with onset within 72 hours prior to study treatment;
  • Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across the 3 most affected contiguous air conduction audiometric pure tone frequencies ("pure tone average", PTA);\*
  • Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conducted PTA frequencies compared with the unaffected contralateral ear or reference values from a pre-existing audiogram or ISO 7029;2000 norm values in case of asymmetric hearing prior to the ISSNHL incident;
  • Age ≥ 18 and ≤ 65 years on the day of screening;

You may not qualify if:

  • Bilateral ISSNHL;
  • Acute hearing loss from noise trauma, barotrauma or head trauma;
  • History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in the affected ear;
  • History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Please check link to study webpage below for more study sites

Sofia, Bulgaria

Location

Related Links

MeSH Terms

Conditions

Hearing LossDeafnessHearing Loss, SensorineuralEar DiseasesHearing DisordersOtorhinolaryngologic DiseasesSensation DisordersSigns and SymptomsSpeech DisordersHearing Loss, Unilateral

Interventions

D-JNKI-1

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesPathological Conditions, Signs and SymptomsLanguage DisordersCommunication DisordersNeurobehavioral Manifestations

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 25, 2015

Study Start

November 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

BU(1)