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: ot Recruiting

Sex: All

Target Recruitment: 240

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 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
•Must be able to read and understand the relevant study documents
•Written informed consent before participation in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
•Any drug-based therapy for otitis media that is ongoing or was performed in the past 2 weeks
•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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