Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus - Full Text View

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:

MedlinePlus related topics: Tinnitus

U.S. FDA Resources

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

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
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases

Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013