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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

• Persistent tinnitus following acute acoustic trauma or sudden deafness or acute otitis media with onset less than three months ago (i.e. acute tinnitus)
• Tinnitus provoking incident of acute acoustic trauma or sudden deafness or acute otitis media is documented by medical report
• 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
• 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, pentoxyfilline, betahistine, diazepam, carbamazepine, sodium valproate and antidepressants
• Concomitant use of any other NMDA receptor antagonist (e.g. memantine, dextromethorphan, ifenprodil)
• Any drug-based therapy for acute otitis media that is ongoing or was performed in the past 2 weeks
• 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy outcome is the change in the minimum masking level (MML)<br /><br>from Baseline to D90. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy endpoints<br /><br>• The change in the minimum masking level (MML) from Baseline to D7 and D30<br /><br>• The change in tinnitus loudness by loudness matching from Baseline to D7,<br /><br>D30, and D90.<br /><br>• Global impression of change questionnaire for tinnitus severity at study<br /><br>completion (D90)<br /><br>• The change in tinnitus annoyance by magnitude estimation from baseline to D7,<br /><br>D30, and D90<br /><br>• The change in tinnitus loudness by magnitude estimation from baseline to D7,<br /><br>D30, and D90.<br /><br>• The change in tinnitus handicap from baseline as measured by the TBF-12<br /><br>questionnaire at D90<br /><br>• The change in sleep impact by magnitude estimation from baseline to D90</p><br>