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

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

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

Study Overview

• Status: Completed
• Conditions: Tinnitus
• Intervention / Treatment: Drug: 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).

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Medpace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 76 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AM-101 injection; AM-101 gel for intratympanic injection	Drug: AM-101; AM-101 gel for intratympanic injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Auris Medical, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: August 15, 2013
• First Submitted That Met QC Criteria: August 29, 2013
• First Posted (ESTIMATE): September 4, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: AM-101-CL-12-03