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

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

Detailed Description
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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).

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

Conditions
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Tinnitus

Intervention / Treatment
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* Drug: AM-101


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AM-101 injection<br>AM-101 gel for intratympanic injection | Drug: AM-101<br>* AM-101 gel for intratympanic injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |