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

This study is not yet open for participant recruitment.
Verified November 2013 by Auris Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01934010
First received: August 15, 2013
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

The purpose of this study is the evaluation of the safety and local tolerance of repeated treatment cycles of AM-101 in subjects previously treated in the scope of the TACTT2 study (NCT01803646).


Condition Intervention Phase
Acute Peripheral 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:
  • Deterioration of hearing threshold equal or larger than 15 dB [ Time Frame: Day 35 and/or day 119 and/or day 203 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 330
Study Start Date: March 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AM-101 injection
AM-101
Drug: AM-101
Gel for i.t. injection

  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;
  • Willing and able to attend the study visits during at least one treatment cycle;
  • Signed Informed Consent Form. 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;
  • Use of other NMDA receptor antagonists
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01934010

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

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: November 29, 2013
Health Authority: United States: Food and Drug Administration

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 April 17, 2014