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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Auris Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01934010
First received: August 15, 2013
Last updated: June 3, 2014
Last verified: June 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    Occurrence of deterioration in hearing threshold in the treated ear(s)


Secondary Outcome Measures:
  • Hearing threshold [ Time Frame: Up to Day 252 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Occurrence and severity of adverse events and serious adverse events


Estimated Enrollment: 330
Study Start Date: June 2014
Estimated Study Completion Date: January 2017
Estimated 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

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934010

Contacts
Contact: Eaton +1.513.579.9911 auris-trials@medpace.com

Locations
United States, Ohio
Medpace Recruiting
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Auris Medical, Inc.
  More Information

No publications provided

Responsible Party: Auris Medical, Inc.
ClinicalTrials.gov Identifier: NCT01934010     History of Changes
Other Study ID Numbers: AM-101-CL-12-03
Study First Received: August 15, 2013
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on July 24, 2014