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AM-101 in the Treatment of Post-Acute Tinnitus 2 (AMPACT2)

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: NCT02040207
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc. ( Auris Medical AG )

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 with 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 with AM-101 in subjects previously treated in the scope of the TACTT3 study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 487 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 2 (AMPACT2) - an Open-Label Extension to the TACTT3 Study
Study Start Date : June 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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. Hearing threshold [ Time Frame: Up to Day 203 ]
    Occurrence of deterioration in hearing threshold in the treated ear(s)


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: Up to Day 252 ]
    Occurrence and severity of adverse events and serious adverse events


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 TACTT3 study;
  • Negative pregnancy test (woman of childbearing potential);
  • Willing and able to attend the study visits.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Adverse event leading to treatment discontinuation in TACTT3;
  • 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): NCT02040207


Locations
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Germany
Investigational site
Munich, Germany
Sponsors and Collaborators
Auris Medical AG
More Information
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Responsible Party: Auris Medical AG
ClinicalTrials.gov Identifier: NCT02040207    
Other Study ID Numbers: AM-101-CL-12-04
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases