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AM-101 in the Treatment of Post-Acute Tinnitus 1 (AMPACT1)

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AM-101
Sponsored by
Auris Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medpace

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AM-101 injection

Arm Description

AM-101 gel for intratympanic injection

Outcomes

Primary Outcome Measures

Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction)
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.
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction)
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.
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction)
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 Outcome Measures

Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction)
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.
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction)
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.
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction)
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.

Full Information

First Posted
August 15, 2013
Last Updated
April 17, 2018
Sponsor
Auris Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01934010
Brief Title
AM-101 in the Treatment of Post-Acute Tinnitus 1
Acronym
AMPACT1
Official Title
AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 (AMPACT1) - an Open-Label Extension to the TACTT2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Auris Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AM-101 injection
Arm Type
Experimental
Arm Description
AM-101 gel for intratympanic injection
Intervention Type
Drug
Intervention Name(s)
AM-101
Intervention Description
AM-101 gel for intratympanic injection
Primary Outcome Measure Information:
Title
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction)
Description
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.
Time Frame
Day 1 (TV1) to Day 35 (FUV2) of cycle 1
Title
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction)
Description
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.
Time Frame
Day 84 (TV4) to Day 119 (FUV5) of cycle 2
Title
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction)
Description
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.
Time Frame
Day 168 (TV7) up to Day 203 (FUV8) of cycle 3
Secondary Outcome Measure Information:
Title
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction)
Description
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.
Time Frame
Day 1 (TV1) to Day 84 (FUV3) of cycle 1
Title
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction)
Description
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.
Time Frame
Day 84 (TV4) to Day 168 (FUV6) of cycle 2
Title
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction)
Description
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.
Time Frame
Day 168 (TV7) to Day 252 (FUV9) of cycle 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Medpace
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States

12. IPD Sharing Statement

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

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