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Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus

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ClinicalTrials.gov Identifier: NCT00860808
Recruitment Status : Completed
First Posted : March 12, 2009
Last Update Posted : February 13, 2013
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc. ( Auris Medical AG )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Tinnitus Drug: AM-101 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Change in the minimum masking level from Baseline to Day 90 [ Time Frame: Day 90 ]

Secondary Outcome Measures :
  1. Standard audiological evaluations [ Time Frame: D7, D30, D90 ]
  2. Questionaires evaluating the impact of tinnitus [ Time Frame: D7, D30, D90 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00860808


Locations
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Germany
Bundeswehrkrankenhaus Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
Auris Medical AG
Investigators
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Study Director: Heinz Maier, MD Bundeswehrkrankenhaus Ulm
More Information
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Responsible Party: Auris Medical AG
ClinicalTrials.gov Identifier: NCT00860808    
Other Study ID Numbers: AM-101-CL-08-01
EudraCT number: 2008-005178-10
First Posted: March 12, 2009    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013
Keywords provided by Auris Medical, Inc. ( Auris Medical AG ):
tinnitus
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases