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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

487 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Tinnitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AM-101 injection

AM-101 gel for intratympanic injection

Group Type EXPERIMENTAL

AM-101

Intervention Type DRUG

AM-101 gel for intratympanic injection

Interventions

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AM-101

AM-101 gel for intratympanic injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No