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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.

Tracking Information
First Submitted Date  ICMJE August 15, 2013
First Posted Date  ICMJE September 4, 2013
Results First Submitted Date  ICMJE February 8, 2018
Results First Posted Date  ICMJE March 9, 2018
Last Update Posted Date May 16, 2018
Study Start Date  ICMJE June 2014
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2013)		 Deterioration of hearing threshold equal or larger than 15 dB [ Time Frame: Day 35 and/or day 119 and/or day 203 ]
Occurrence of deterioration in hearing threshold from before the start of each treatment cycle to the corresponding 35-day-Follow-Up Visit of the respective treatment cycle.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2013)
  • Deterioration of hearing threshold equal or larger than 15 dB [ Time Frame: Up to day 84, or up to day 168, or up to day 252 ]
    Difference and occurence of deterioration of hearing
  • Occurrence and severity of adverse events and serious adverse events [ Time Frame: Up to day 84, or up to day 168, or up to day 252 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AM-101 in the Treatment of Post-Acute Tinnitus 1
Official Title  ICMJE AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 (AMPACT1) - an Open-Label Extension to the TACTT2 Study
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE Drug: AM-101
AM-101 gel for intratympanic injection
Study Arms  ICMJE Experimental: AM-101 injection
AM-101 gel for intratympanic injection
Intervention: Drug: AM-101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2017)		 260
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2013)		 330
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 76 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01934010
Other Study ID Numbers  ICMJE AM-101-CL-12-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Auris Medical, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Auris Medical, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Auris Medical, Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP