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

NCT01934010 | Completed Phase 3 Results

• 1 other identifier: AM-101-CL-12-03
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction)

  Day 1 (TV1) to Day 84 (FUV3) of cycle 1

• Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction)

  Day 84 (TV4) to Day 168 (FUV6) of cycle 2

• Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction)

  Day 168 (TV7) to Day 252 (FUV9) of cycle 3

Study Arms (1)

AM-101 injection

EXPERIMENTAL

AM-101 gel for intratympanic injection

Drug: AM-101

Interventions

AM-101 DRUG

AM-101 gel for intratympanic injection

AM-101 injection

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Auris Medical, Inc.: lead

Study Sites (1)

Medpace

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Tinnitus

Interventions

PDCD5 protein, rat

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Thomas Meyer, CEO
• Organization: Auris Medical Inc.

hear@aurismedical.com

+1 312 396 4150

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: September 4, 2013
• Study Start: June 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 16, 2018
• Results First Posted: March 9, 2018

Record last verified: 2018-04

Locations

US (1)