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

Tinnitus Clinical Trial

— AMPACT2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040207
• Other study ID #: AM-101-CL-12-04
• Status: Completed
• Phase: Phase 3
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2023
• Source: Auris Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 487
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

Drug:
• AM-101
AM-101 gel for intratympanic injection

Locations

Country	Name	City	State
Germany	Investigational site	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Auris Medical AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing threshold	Occurrence of deterioration in hearing threshold in the treated ear(s)	Up to Day 203
Secondary	Hearing threshold	Difference and occurence of deterioration of hearing threshold in the treated ear(s)	Up to Day 252
Secondary	Adverse events and serious adverse events	Occurrence and severity of adverse events and serious adverse events	Up to Day 252

External Links

•   Link to Result entry in clinicaltrialsregister.eu