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AM-101 in the Treatment of Post-Acute Tinnitus 1 (AMPACT1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01934010
Recruitment Status : Completed
First Posted : September 4, 2013
Results First Posted : March 9, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc.

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

Condition or disease Intervention/treatment Phase
Tinnitus Drug: AM-101 Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 (AMPACT1) - an Open-Label Extension to the TACTT2 Study
Study Start Date : June 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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Arm Intervention/treatment
Experimental: AM-101 injection
AM-101 gel for intratympanic injection
 Drug: AM-101
AM-101 gel for intratympanic injection


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.



Secondary Outcome Measures :
  1. 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 ]

    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.


  2. 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 ]

    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. 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 ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934010


Locations
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United States, Ohio
Medpace
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Auris Medical, Inc.
More Information
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Responsible Party: Auris Medical, Inc.
ClinicalTrials.gov Identifier: NCT01934010    
Other Study ID Numbers: AM-101-CL-12-03
First Posted: September 4, 2013    Key Record Dates
Results First Posted: March 9, 2018
Last Update Posted: May 16, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases