- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02040207
AM-101 in the Treatment of Post-Acute Tinnitus 2 (AMPACT2)
September 13, 2023 updated by: Auris Medical AG
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Munich, Germany
- Investigational site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AM-101 injection
AM-101 gel for intratympanic injection
|
AM-101 gel for intratympanic injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hearing threshold
Time Frame: Up to Day 203
|
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
Time Frame: Up to Day 252
|
Difference and occurence of deterioration of hearing threshold in the treated ear(s)
|
Up to Day 252
|
Adverse events and serious adverse events
Time Frame: Up to Day 252
|
Occurrence and severity of adverse events and serious adverse events
|
Up to Day 252
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- AM-101-CL-12-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tinnitus
-
State University of New York at BuffaloUniversity at BuffaloCompletedTinnitus, Subjective | Tinnitus | Noise Induced Tinnitus | Tinnitus, Objective | Tinnitus Aggravated | Tinnitus, Pulsatile | Tinnitus, Spontaneous Oto-Acoustic Emission | Tinnitus, Clicking | Tinnitus, Tensor Tympani InducedUnited States
-
Mohab MohammedNot yet recruitingPulsatile Tinnitus (Diagnosis)
-
Philipps University Marburg Medical CenterLinkoeping University; Eriksholm Research Centre; University Hospital of Gießen...CompletedTinnitus | Subjective Tinnitus | Chronic TinnitusGermany
-
University of GuadalajaraHospital Civil de Guadalajara; Institute of Experimental and Clinical TherapeuticsRecruitingOxidative Stress | Tinnitus, Subjective | Tinnitus, Bilateral | Antioxidant Therapy | Psychiatric Drugs | Inflammatory Cytokines | SSRIMexico
-
University Hospital, BordeauxNot yet recruiting
-
Cairo UniversityRecruiting
-
University of ZurichRecruitingTinnitus, Subjective | TinnitusSwitzerland
-
Eye & ENT Hospital of Fudan UniversityNot yet recruiting
-
University of Illinois at Urbana-ChampaignGN Hearing A/SActive, not recruitingTinnitus, SubjectiveUnited States
-
University of ZurichCompletedTinnitus, SubjectiveGermany, Switzerland
Clinical Trials on AM-101
-
Auris Medical, Inc.Completed
-
Auris Medical AGCompleted
-
Auris Medical, Inc.Completed
-
Auris Medical, Inc.CompletedTinnitusUnited States, Germany, Belgium, Poland
-
Istanbul University - Cerrahpasa (IUC)Not yet recruitingSleep Quality | Mother-Infant Interaction | AttachmentTurkey
-
University of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not yet recruitingHealthy | Overweight and ObesityUnited States
-
AllerganCompletedBlue Light DamageUnited States
-
Providence HealthcareCompletedRehabilitation | Psychological Distress | Psychological StressCanada
-
Auris Medical AGCompleted