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

Tinnitus Clinical Trial

— AMPACT1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934010
• Other study ID #: AM-101-CL-12-03
• Status: Completed
• Phase: Phase 3
• Start date: June 2014
• Est. completion date: January 2017

Study information

• Verified date: April 2018
• Source: Auris Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

Drug:
• AM-101
AM-101 gel for intratympanic injection

Locations

Country	Name	City	State
United States	Medpace	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Auris Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 (TV1) to Day 35 (FUV2) of cycle 1
Primary	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.	Day 84 (TV4) to Day 119 (FUV5) of cycle 2
Primary	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.	Day 168 (TV7) up to Day 203 (FUV8) of cycle 3
Secondary	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.	Day 1 (TV1) to Day 84 (FUV3) of cycle 1
Secondary	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.	Day 84 (TV4) to Day 168 (FUV6) of cycle 2
Secondary	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.	Day 168 (TV7) to Day 252 (FUV9) of cycle 3