AM-101 in the Treatment of Acute Tinnitus 3 (TACTT3)

September 13, 2023 updated by: Auris Medical AG

Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3

The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months or within the last >3 to 6 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratympanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months (Stratum A), or between >3 and 6 months (Stratum B) from onset).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
893

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
      • Munich, Germany
        • Please check the study webpage below for a study site list

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Persistent subjective peripheral tinnitus (unilateral or bilateral) following traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer than 3 months (Stratum A) or between >3 months and 6 months (Stratum B) prior to randomization, as documented by medical report or by documented medical history. Upon implementation of protocol amendment 6, subjects with tinnitus following traumatic cochlear injury will only be eligible if they are affected only unilaterally.
  2. Age ≥ 18 years and ≤ 75 years;
  3. Negative pregnancy test (woman of childbearing potential);
  4. Willing and able to use adequate hearing protection, respectively to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured;
  5. Willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  1. Fluctuating tinnitus;
  2. Intermittent tinnitus;
  3. Tinnitus resulting from traumatic head or neck injury;
  4. Presence of chronic tinnitus;
  5. Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss;
  6. History of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma;
  7. Ongoing acute or chronic otitis media or otitis externa;
  8. Other treatment of tinnitus for the study duration;
  9. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction;
  10. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
  11. Women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months;
  12. Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AM-101 injection
AM-101
Drug: AM-101
AM-101 gel for intratympanic injection
Placebo Comparator: Placebo injection
Placebo
Drug: Placebo
Placebo gel for intratympanic injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy endpoint - alternate primary efficacy endpoints: Tinnitus Functional Index (TFI)
Time Frame: Baseline to Day 84
Improvement in TFI total score
Baseline to Day 84
Efficacy endpoint - alternate primary efficacy endpoints: Patient-reported Tinnitus loudness on a Numerical Rating Scale (TLQ NRS loudest)
Time Frame: Baseline to Day 84
Improvement in TLQ NRS loudest
Baseline to Day 84
Safety endpoint: Hearing threshold
Time Frame: Baseline to Day 35
Occurrence of deterioration in hearing threshold >= 15 decibel (dB) at the average of two contiguous test frequencies (air conduction) in the treated ear(s)
Baseline to Day 35

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy endpoint - TFI
Time Frame: Baseline to Day 10 and Day 35
Improvement in TFI total score
Baseline to Day 10 and Day 35
Efficacy endpoint - TLQ NRS loudest
Time Frame: Baseline to Day 10 and Day 35
Improvement in patient-reported tinnitus loudness
Baseline to Day 10 and Day 35
Efficacy endpoint - patient-reported tinnitus annoyance (TAQ NRS worst)
Time Frame: Baseline to Day10, Day 35 and Day 84
Improvement in TAQ NRS worst
Baseline to Day10, Day 35 and Day 84
Efficacy endpoint - TFI sleep score
Time Frame: Baseline to Day10, Day 35 and Day 84
Improvement in TFI sleep score. The subscale "sleep" will be evaluated only for subjects with a TFI Sleep score greater than 0 at baseline.
Baseline to Day10, Day 35 and Day 84
Efficacy endpoint - Patient global impression of change in tinnitus severity (PGIC Tinnitus)
Time Frame: at Day10, Day 35 and Day 84
Patient global impression of change in tinnitus severity
at Day10, Day 35 and Day 84
Safety endpoint - Hearing threshold
Time Frame: Baseline to Day 1, Day 2, Day 10 and Day 84
Occurrence of deterioration in hearing threshold >= 15 dB at the average of two contiguous test frequencies in the treated ear(s)
Baseline to Day 1, Day 2, Day 10 and Day 84
Safety endpoint - Hearing threshold
Time Frame: Baseline to Day 1, Day 2, Day 10 and Day 84
Difference in occurrence of deterioration in hearing threshold >= 15 dB at the average of two contiguous test frequencies between the treated and untreated contralateral ear (subjects with unilaterally treated tinnitus only)
Baseline to Day 1, Day 2, Day 10 and Day 84
Safety endpoint - AEs and SAEs
Time Frame: Up to Day 84
Occurence and severity of adverse events (AEs) and serious adverse Events (SAEs), differentiated by relatedness, and by treatment-emergence and procedure-emergence
Up to Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Auris Medical AG

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AM-101-CL-12-02

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.

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