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Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc. ( Auris Medical AG )
ClinicalTrials.gov Identifier:
NCT00860808
First received: March 11, 2009
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

The purpose of the study is the evaluation of the therapeutic benefit of intratympanic AM 101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus following acute sensorineural hearing loss.


Condition Intervention Phase
Tinnitus
Drug: AM-101
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Multiple Dose, Group Comparison Phase II Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in the minimum masking level from Baseline to Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Standard audiological evaluations [ Time Frame: D7, D30, D90 ] [ Designated as safety issue: No ]
  • Questionaires evaluating the impact of tinnitus [ Time Frame: D7, D30, D90 ] [ Designated as safety issue: No ]

Enrollment: 248
Study Start Date: March 2009
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 AM-101
low dose
Drug: AM-101
Triple intratympanic injection (one on each day 1, 2, and 3)
Experimental: 2 AM-101
high dose
Drug: AM-101
Triple intratympanic injection (one on each day 1, 2, and 3)
Placebo Comparator: 3 Placebo Drug: AM-101
Triple intratympanic injection (one on each day 1, 2, and 3)

Detailed Description:

Tinnitus may seriously impact the ability to sleep, relax, or to concentrate, or lead to tiredness, irritation, nervousness, despair, frustration, or depression, thus severely impacting the quality of life and health of the affected person. To date, there exists no pharmaceutical treatment for persisting tinnitus.

Non-clinical studies with AM-101 have shown that the inhibition of cochlear NMDA receptors is successful in suppressing tinnitus without affecting normal glutamate neurotransmission respectively hearing function. In particular, it could be demonstrated that local administration of AM-101 in a single dose resulted in a complete suppression of tinnitus induced by acute acoustic trauma without any relapse thereafter.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent tinnitus following acute acoustic trauma, sudden deafness, or acute otitis media with onset less than three months ago (i.e. acute tinnitus)
  • Tinnitus provoking incident of acute acoustic trauma, sudden deafness or acute otitis media is documented by audiogram and medical report and at onset resulted in an inner ear hearing loss of at least 15 dB in two adjacent frequencies
  • Minimum Masking Level (MML) of at least 5 dB SL
  • Age ≥ 18 years and ≤ 65 years
  • Negative pregnancy test for women of childbearing potential
  • Willing and able to attend the on-study visits
  • Must be able to read and understand the relevant study documents
  • Written informed consent before participation in the study

Exclusion Criteria:

  • Tinnitus that is not completely maskable
  • Fluctuating tinnitus
  • Intermittent tinnitus
  • Meniere's Disease
  • Acute or chronic otitis media or otitis externa
  • Any ongoing therapy known as potentially tinnitus-inducing (e.g. aminoglycosides, cisplatin, loop diuretics, high doses of aspirin, quinine etc.)
  • Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 2 weeks, e.g. prednisolone, dexamethasone, pentoxifylline, betahistine, diazepam, carbamazepine, sodium valproate and antidepressants
  • Concomitant use of any other NMDA receptor antagonist (e.g. memantine, dextromethorphan, ifenprodil)
  • Any ongoing or planned concomitant medication for the treatment of tinnitus until 90 days after study drug application
  • History or presence of drug abuse or alcoholism
  • Any clinically relevant respiratory, cardiovascular, neurological (except vertigo), or psychiatric disorder
  • Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction
  • Women who are breast-feeding, pregnant or who plan a pregnancy during the trial
  • Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner
  • Concurrent participation in another clinical trial with an investigational drug or participation in another clinical trial with an investigational drug within 30 days prior to study entry
  • Any drug-based therapy for otitis media that is ongoing or was performed in the past 2 weeks
  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: NCT00860808

Locations
Germany
Bundeswehrkrankenhaus Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
Auris Medical AG
Investigators
Study Director: Heinz Maier, MD Bundeswehrkrankenhaus Ulm
  More Information

No publications provided

Responsible Party: Auris Medical, Inc. ( Auris Medical AG )
ClinicalTrials.gov Identifier: NCT00860808     History of Changes
Other Study ID Numbers: AM-101-CL-08-01, EudraCT number: 2008-005178-10
Study First Received: March 11, 2009
Last Updated: February 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: The Central Register of Clinical Trials

Keywords provided by Auris Medical, Inc.:
tinnitus

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

ClinicalTrials.gov processed this record on November 25, 2014