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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Auris Medical, Inc.

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.

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.