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Completed

NCT Number: NCT01934010

AM-101 in the Treatment of Post-Acute Tinnitus 1

The purpose of this research study is to test the safety and local tolerance of repeated treatment cycles of AM-101.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medpace

Cincinnati, Ohio, 45227, United States

About this study

This open-label extension study is assessing the safety and local tolerance of repeated treatment cycles of AM-101 in subjects previously treated in the scope of the TACTT2 study (NCT01803646).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Completion of TACTT2 study;
  • Negative pregnancy test (woman of childbearing potential);
  • Willing and able to attend the study visits during at least one treatment cycle.

Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Adverse event leading to treatment discontinuation in TACTT2;
  • Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane;
  • Ongoing drug-based therapy for otitis media or otitis externa;
  • Drug-based therapy known as potentially tinnitus-inducing;
  • Other treatment of tinnitus;
  • Drug abuse or alcoholism;
  • Subjects with psychiatric diseases requiring drug treatment;
  • Use of antidepressant or anti-anxiety medication;
  • Any clinically relevant disorder or abnormality in physical examination;
  • Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
  • Women of childbearing potential who are unwilling or unable to practice contraception.

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

AM-101

Drug

AM-101 gel for intratympanic injection

Primary outcomes

  1. Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction)

    Time frame: Day 1 (TV1) to Day 35 (FUV2) of cycle 1

    Valid for Safety Analysis Set was used.

    Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.

    The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.

  2. Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction)

    Time frame: Day 84 (TV4) to Day 119 (FUV5) of cycle 2

    Valid for Safety Analysis Set was used.

    Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.

    The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.

  3. Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction)

    Time frame: Day 168 (TV7) up to Day 203 (FUV8) of cycle 3

    Valid for Safety Analysis Set was used.

    Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.

    The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.

Secondary outcomes

  1. Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction)

    Time frame: Day 1 (TV1) to Day 84 (FUV3) of cycle 1

    Valid for Safety Analysis Set was used.

    Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.

    The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.

  2. Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction)

    Time frame: Day 84 (TV4) to Day 168 (FUV6) of cycle 2

    Valid for Safety Analysis Set was used.

    Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.

    The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.

  3. Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction)

    Time frame: Day 168 (TV7) to Day 252 (FUV9) of cycle 3

    Valid for Safety Analysis Set was used.

    Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.

    The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.

Sponsors and collaborators

Lead sponsor

Auris Medical, Inc.

Industry

Registry information

Official study title

AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 (AMPACT1) - an Open-Label Extension to the TACTT2 Study

Acronym: AMPACT1

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 4, 2013
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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