AM-101 in the Treatment of Post-Acute Tinnitus 2 (AMPACT2)

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

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

Study Overview

• Status: Completed
• Conditions: Tinnitus
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 487
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany
    • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AM-101 injection; AM-101 gel for intratympanic injection	Drug: AM-101; AM-101 gel for intratympanic injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Auris Medical AG

Publications and helpful links

Helpful Links

• Link to Result entry in clinicaltrialsregister.eu

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 14, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimated): January 20, 2014

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: AM-101-CL-12-04