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

Completed · Phase 3

Conditions studied: Tinnitus

In brief

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

Key facts

Study ID

NCT01934010

Run by

Auris Medical, Inc.

People needed

260

Starts

2014-06-01

Expected to finish

2017-01-01

Last updated by the study team

2018-05-16

Who can join

Age: 18 and older, up to 76. Sex: any. Healthy volunteers: not accepted.

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.
• Other protocol-defined inclusion criteria may apply.

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.
• Other protocol-defined exclusion criteria may apply.

Where it is running

• Medpace — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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