Try the modernized beta website. Learn more about the modernization effort.
Working… Menu
Trial record 6 of 7 for:    am101

Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00860808
Recruitment Status : Completed
First Posted : March 12, 2009
Last Update Posted : February 13, 2013
Information provided by (Responsible Party):
Auris Medical, Inc. ( Auris Medical AG )

Tracking Information
First Submitted Date  ICMJE March 11, 2009
First Posted Date  ICMJE March 12, 2009
Last Update Posted Date February 13, 2013
Study Start Date  ICMJE March 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2009)
Change in the minimum masking level from Baseline to Day 90 [ Time Frame: Day 90 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2009)
  • Standard audiological evaluations [ Time Frame: D7, D30, D90 ]
  • Questionaires evaluating the impact of tinnitus [ Time Frame: D7, D30, D90 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE Drug: AM-101
Triple intratympanic injection (one on each day 1, 2, and 3)
Study Arms  ICMJE
  • Experimental: 1 AM-101
    low dose
    Intervention: Drug: AM-101
  • Experimental: 2 AM-101
    high dose
    Intervention: Drug: AM-101
  • Placebo Comparator: 3 Placebo
    Intervention: Drug: AM-101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2011)
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2009)
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00860808
Other Study ID Numbers  ICMJE AM-101-CL-08-01
EudraCT number: 2008-005178-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Auris Medical, Inc. ( Auris Medical AG )
Original Responsible Party Dr. Thomas Meyer, Auris Medical AG
Current Study Sponsor  ICMJE Auris Medical AG
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Heinz Maier, MD Bundeswehrkrankenhaus Ulm
PRS Account Auris Medical, Inc.
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP