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Trial record 1 of 1 for:    NCT01934010
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AM-101 in the Treatment of Post-Acute Tinnitus 1 (AMPACT1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01934010
First Posted: September 4, 2013
Last Update Posted: January 27, 2017
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.
Information provided by (Responsible Party):
Auris Medical, Inc.
  Purpose
The purpose of this research study is to test the safety and local tolerance of repeated treatment cycles of AM-101.

Condition Intervention Phase
Tinnitus Drug: AM-101 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Auris Medical, Inc.:

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


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

  • Adverse events and serious adverse events [ Time Frame: Throughout subject study participation ]
    Occurrence and severity of adverse events and serious adverse events


Enrollment: 260
Study Start Date: June 2014
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AM-101 injection
AM-101 gel for intratympanic injection
Drug: AM-101
AM-101 gel for intratympanic injection

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).
  Eligibility

Information from the National Library of Medicine

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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.

  Contacts and Locations
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.
  More Information

Responsible Party: Auris Medical, Inc.
ClinicalTrials.gov Identifier: NCT01934010     History of Changes
Other Study ID Numbers: AM-101-CL-12-03
First Submitted: August 15, 2013
First Posted: September 4, 2013
Last Update Posted: January 27, 2017
Last Verified: January 2017

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