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Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
AM-101
Sponsored by
Auris Medical AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bundeswehrkrankenhaus Ulm

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1 AM-101

2 AM-101

3 Placebo

Arm Description

low dose

high dose

Outcomes

Primary Outcome Measures

Change in the minimum masking level from Baseline to Day 90

Secondary Outcome Measures

Standard audiological evaluations
Questionaires evaluating the impact of tinnitus

Full Information

First Posted
March 11, 2009
Last Updated
February 12, 2013
Sponsor
Auris Medical AG
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1. Study Identification

Unique Protocol Identification Number
NCT00860808
Brief Title
Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Auris Medical AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 AM-101
Arm Type
Experimental
Arm Description
low dose
Arm Title
2 AM-101
Arm Type
Experimental
Arm Description
high dose
Arm Title
3 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AM-101
Intervention Description
Triple intratympanic injection (one on each day 1, 2, and 3)
Primary Outcome Measure Information:
Title
Change in the minimum masking level from Baseline to Day 90
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Standard audiological evaluations
Time Frame
D7, D30, D90
Title
Questionaires evaluating the impact of tinnitus
Time Frame
D7, D30, D90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinz Maier, MD
Organizational Affiliation
Bundeswehrkrankenhaus Ulm
Official's Role
Study Director
Facility Information:
Facility Name
Bundeswehrkrankenhaus Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

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Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus

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