AM-101 in the Treatment of Post-Acute Tinnitus 2

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02040207

Acronym

AMPACT2

Enrollment

487

Registered

2014-01-20

Start date

2014-06-30

Completion date

2016-12-31

Last updated

2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Brief summary

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

Detailed 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.

Interventions

DRUGAM-101

AM-101 gel for intratympanic injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 76 Years

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. Other protocol-defined

Design outcomes

Primary

Measure	Time frame	Description
Hearing threshold	Up to Day 203	Occurrence of deterioration in hearing threshold in the treated ear(s)

Secondary

Measure	Time frame	Description
Hearing threshold	Up to Day 252	Difference and occurence of deterioration of hearing threshold in the treated ear(s)
Adverse events and serious adverse events	Up to Day 252	Occurrence and severity of adverse events and serious adverse events

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026