AM-101 in the Treatment of Post-Acute Tinnitus 2 (AMPACT2)

Auris Medical

Status and phase

Completed

Phase 3

Conditions

Tinnitus

Treatments

Drug: AM-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT02040207

AM-101-CL-12-04

Details and patient eligibility

About

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

Full description

This open-label extension study is assessing the safety and local tolerance of repeated treatment with AM-101 in subjects previously treated in the scope of the TACTT3 study.

Enrollment

487 patients

Sex

All

Ages

18 to 76 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Completion of TACTT3 study;
Negative pregnancy test (woman of childbearing potential);
Willing and able to attend the study visits.

Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Adverse event leading to treatment discontinuation in TACTT3;
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.