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

NCT ID: NCT01934010

Last Updated: 2018-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-01-31

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).

Conditions

Tinnitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AM-101 injection

AM-101 gel for intratympanic injection

Group Type: EXPERIMENTAL

AM-101

Intervention Type: DRUG

AM-101 gel for intratympanic injection

Interventions

AM-101

AM-101 gel for intratympanic injection

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Auris Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medpace

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

AM-101-CL-12-03

Identifier Type: -

Identifier Source: org_study_id