AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 2 (AMPACT2) - an Open-Label Extension to the TACTT3 Study

AM-101-CL-12-04

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

2014-06-01

2016-12-01

2016-12-01

Completed

Early phase I

487

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. Other protocol-defined exclusion criteria may apply.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 487, 'type': 'ACTUAL'}}

2023-09-14