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

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ClinicalTrials.gov Identifier: NCT01934010
Recruitment Status : Completed
First Posted : September 4, 2013
Results First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc.

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
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
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Frequency of Subjects With a Deterioration of Hearing Threshold (Air Conduction) [ Time Frame: Up to Day 203 ]

    Valid for Safety Analysis Set was used. Please note that subjects with hearing deterioration are counted per arm and not per treatment cycle.

    This means that in Arm 1 deteriorations are counted for subjects that participated solely in 1 Cycle.


  2. Frequency of Subjects With a Deterioration of Hearing Threshold (Bone Conduction) [ Time Frame: Up to Day 203 ]

    Valid for Safety Analysis Set was used. Please note that subjects with hearing deterioration are counted per arm and not per treatment cycle.

    This means that in Arm 1 deteriorations are counted for subjects that participated solely in 1 Cycle.



Secondary Outcome Measures :
  1. Hearing Threshold [ Time Frame: Up to Day 252 ]
    Difference and occurence of deterioration of hearing threshold in the treated ear(s)

  2. Adverse Events and Serious Adverse Events [ Time Frame: Throughout subject study participation ]
    Occurrence and severity of adverse events and serious adverse events



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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Senior)
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.


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
United States, Ohio
Medpace
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Auris Medical, Inc.

Responsible Party: Auris Medical, Inc.
ClinicalTrials.gov Identifier: NCT01934010     History of Changes
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: March 9, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms