Back to resultsAM-101 in the Treatment of Post-Acute Tinnitus 2 (AMPACT2)
Primary Purpose
Tinnitus
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
AM-101
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
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.
Sites / Locations
- Investigational site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AM-101 injection
Arm Description
AM-101 gel for intratympanic injection
Outcomes
Primary Outcome Measures
Hearing threshold
Occurrence of deterioration in hearing threshold in the treated ear(s)
Secondary Outcome Measures
Hearing threshold
Difference and occurence of deterioration of hearing threshold in the treated ear(s)
Adverse events and serious adverse events
Occurrence and severity of adverse events and serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02040207
Brief Title
AM-101 in the Treatment of Post-Acute Tinnitus 2
Acronym
AMPACT2
Official Title
AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 2 (AMPACT2) - an Open-Label Extension to the TACTT3 Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Auris Medical AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
487 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AM-101 injection
Arm Type
Experimental
Arm Description
AM-101 gel for intratympanic injection
Intervention Type
Drug
Intervention Name(s)
AM-101
Intervention Description
AM-101 gel for intratympanic injection
Primary Outcome Measure Information:
Title
Hearing threshold
Description
Occurrence of deterioration in hearing threshold in the treated ear(s)
Time Frame
Up to Day 203
Secondary Outcome Measure Information:
Title
Hearing threshold
Description
Difference and occurence of deterioration of hearing threshold in the treated ear(s)
Time Frame
Up to Day 252
Title
Adverse events and serious adverse events
Description
Occurrence and severity of adverse events and serious adverse events
Time Frame
Up to Day 252
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Investigational site
City
Munich
Country
Germany
12. IPD Sharing Statement
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001527-39/results
Description
Link to Result entry in clinicaltrialsregister.eu
Learn more about this trial
AM-101 in the Treatment of Post-Acute Tinnitus 2
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