TinnitusPhase 3AMPACT1NCT01934010

AM-101 in the Treatment of Post-Acute Tinnitus 1

A Phase 3 study testing AM-101 in people with Tinnitus, run by Auris Medical, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 76 years
Conditions the study is for: Tinnitus
What is being tested?: AM-101
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 260 participants
Where: 1 siteUnited States
Study dates: Jun 2014to Jan 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 76 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Completion of TACTT2 study;
Negative pregnancy test (woman of childbearing potential);
Willing and able to attend the study visits during at least one treatment cycle.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Adverse event leading to treatment discontinuation in TACTT2;
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;

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medpace
Cincinnati, Ohio, 45227

Other trials in United States

About this study

Official title: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 (AMPACT1) - an Open-Label Extension to the TACTT2 Study

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

Read the detailed description

This open-label extension study is assessing the safety and local tolerance of repeated treatment cycles of AM-101 in subjects previously treated in the scope of the TACTT2 study (NCT01803646).

Conditions: Tinnitus
Being tested: AM-101
Medical subject headings: Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AM-101Drug
AM-101 gel for intratympanic injection

Study groups in NCT01934010
Study group	Role	What they receive
AM-101 injection	Experimental	AM-101 gel for intratympanic injection Receives: Drug: AM-101

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction)
Valid for Safety Analysis Set was used.
Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.
The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.
Measured: Day 1 (TV1) to Day 35 (FUV2) of cycle 1
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction)
Valid for Safety Analysis Set was used.
Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.
The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.
Measured: Day 84 (TV4) to Day 119 (FUV5) of cycle 2
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction)
Valid for Safety Analysis Set was used.
Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.
The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.
Measured: Day 168 (TV7) up to Day 203 (FUV8) of cycle 3

Secondary outcomes (3)

Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction)
Valid for Safety Analysis Set was used.
Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.
The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.
Measured: Day 1 (TV1) to Day 84 (FUV3) of cycle 1
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction)
Valid for Safety Analysis Set was used.
Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.
The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.
Measured: Day 84 (TV4) to Day 168 (FUV6) of cycle 2
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction)
Valid for Safety Analysis Set was used.
Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.
The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.
Measured: Day 168 (TV7) to Day 252 (FUV9) of cycle 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Jan 2017

First posted4 Sep 2013 (estimated)
Study startJun 2014
Primary completionJan 2017
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TinnitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01934010
Sponsor's protocol ID: AM-101-CL-12-03
Acronym: AMPACT1
Status last verified: Apr 2018
First submitted: 15 Aug 2013
Last updated: 16 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus

All Tinnitus trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 (AMPACT1) - an Open-Label Extension to the TACTT2 Study
ClinicalTrials.gov ID: NCT01934010
Acronym / sponsor ID: AMPACT1 / AM-101-CL-12-03
Conditions: Tinnitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: Auris Medical, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Jan 2017 (actual)
Study completion: Jan 2017 (actual)
First posted: 4 Sep 2013 (estimated)
Results: Posted 9 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

This open-label extension study is assessing the safety and local tolerance of repeated treatment cycles of AM-101 in subjects previously treated in the scope of the TACTT2 study (NCT01803646).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AM-101 injection	Experimental	Drug: AM-101AM-101 gel for intratympanic injection

Who may qualify

Ages: 18 to 76 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Completion of TACTT2 study;
Negative pregnancy test (woman of childbearing potential);
Willing and able to attend the study visits during at least one treatment cycle.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (12 listed)

Adverse event leading to treatment discontinuation in TACTT2;
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AM-101AM-101 gel for intratympanic injection	Drug	AM-101 injection

Primary outcome

Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction)
Time frame: Day 1 (TV1) to Day 35 (FUV2) of cycle 1
Valid for Safety Analysis Set was used. Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound. The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction)
Time frame: Day 84 (TV4) to Day 119 (FUV5) of cycle 2
Valid for Safety Analysis Set was used. Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound. The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction)
Time frame: Day 168 (TV7) up to Day 203 (FUV8) of cycle 3
Valid for Safety Analysis Set was used. Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound. The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies.

3 secondary outcomes

Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction)
Time frame: Day 1 (TV1) to Day 84 (FUV3) of cycle 1
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction)
Time frame: Day 84 (TV4) to Day 168 (FUV6) of cycle 2
Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction)
Time frame: Day 168 (TV7) to Day 252 (FUV9) of cycle 3

Results and safety

Results posted to the registry on 9 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1 Cycle AM-101	114	91
2 Cycles AM-101	67	56
3 Cycles AM-101	76	74

Primary outcome: Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction)

Time frame: Day 1 (TV1) to Day 35 (FUV2) of cycle 1. Number. Unit: Number subject affected

Measure	1 Cycle AM-101 n = 103	2 Cycles AM-101 n = 67	3 Cycles AM-101 n = 74
Value	10	2	2

1 Cycle AM-101 vs 2 Cycles AM-101: p = 0.128, Fisher Exact
1 Cycle AM-101 vs 3 Cycles AM-101: p = 0.075, Fisher Exact
2 Cycles AM-101 vs 3 Cycles AM-101: p = 1, Fisher Exact

Population analysed: The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available.

Primary outcome: Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction)

Time frame: Day 84 (TV4) to Day 119 (FUV5) of cycle 2. Number. Unit: Number subject affected

Measure	2 Cycles AM-101 n = 59	3 Cycles AM-101 n = 75
Value	1	0

2 Cycles AM-101 vs 3 Cycles AM-101: p = 0.4403, Fisher Exact

Population analysed: The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available. Subjects from Cycle 1 did not participate in Cycle 2 and 3 and are therefore "zero".

Primary outcome: Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction)

Time frame: Day 168 (TV7) up to Day 203 (FUV8) of cycle 3. Number. Unit: Number subject affected

Measure	3 Cycles AM-101 n = 74
Value	2

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline to end of study at all visits, up to Day 252.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 Cycle AM-101	2 of 114 (1.8%)	25 of 114 (21.9%)	Not reported
2 Cycles AM-101	1 of 67 (1.5%)	25 of 67 (37.3%)	Not reported
3 Cycles AM-101	1 of 76 (1.3%)	37 of 76 (48.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tinnitus

Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
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Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
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Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AM-101 in people with Tinnitus, run by Auris Medical, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction) (time frame: Day 1 (TV1) to Day 35 (FUV2) of cycle 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01934010.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.