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

Phase 3

Completed

Conditions: Tinnitus

Interventions: Drug: AM-101

Registration Number: NCT01934010

Lead Sponsor: Auris Medical, Inc.

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 260

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AM-101 injection	AM-101	AM-101 gel for intratympanic injection

Primary Outcome Measures

Name	Time	Method
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction)	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.
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction)	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.
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction)	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.

Secondary Outcome Measures

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