AM-101 in the Treatment of Post-Acute Tinnitus 2
Phase 3
Completed
- Conditions
- Tinnitus
- Interventions
- Drug: AM-101
- Registration Number
- NCT02040207
- Lead Sponsor
- Auris Medical AG
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AM-101 injection AM-101 AM-101 gel for intratympanic injection
- Primary Outcome Measures
Name Time Method Hearing threshold Up to Day 203 Occurrence of deterioration in hearing threshold in the treated ear(s)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Investigational site
🇩🇪Munich, Germany