Safety of AM-101 in Patients with Acute Inner Ear Tinnitus from Noise Trauma: a Dose-Finding Phase I/II Study

Conditions: Inner ear tinnitus
MedDRA version: 8.1Level: LLTClassification code 10043882Term: Tinnitus

Registration Number: EUCTR2006-002692-41-DE

Lead Sponsor: aboratoires Auris SAS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Men or female patients = 18 years and = 60 years
Permanent, stable, single tinnitus induced by acute acoustic trauma or sudden deafness*
Tinnitus on-set must have occurred within the past 3 months
Tinnitus has been refractory to a treatment protocol of 14 day prednisolone administration
Washout period of 2 weeks between end of prednisolone protocol and study inclusion
Tinnitus severity at least grade 3 on the 4 grade Biesinger scale

* Guideline Sudden Deafness” of the German Society for Otorhinolaryngology, Head and Neck Surgery (Leitlinie Hörsturz” der Deutschen Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie): Sudden deafness is a suddenly occurring, usually unilateral sensorineural hearing loss of varying severity up to complete deafness without any apparent reason. It may be accompanied by dizziness and/or tinnitus.”
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Active ear infection or ongoing therapy for middle ear disease
Any ongoing or planned concomitant tinnitus therapy
Any medication for the treatment of tinnitus in the 2 weeks prior to study inclusion
Any ongoing therapy known as potentially tinnitus-inducing (e.g. aminoglycosides, cisplatin, loop diuretics, high doses of aspirin, quinine etc.)
Women who are breast-feeding, pregnant or who plan a pregnancy during the trial
Any medication for which concomitant administration with NMDA antagonists is contra-indicated
Use of any other NMDA receptor antagonist
Any clinically relevant respiratory, cardiovascular, neurological, or psychiatric disorder

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the tolerability of the dose range expected to be needed for later clinical studies and to determine the nature of adverse reactions that can be expected;Secondary Objective: Preliminary evaluation of the potential therapeutic benefit of AM-101 in the treatment of inner ear tinnitus as well as the evaluation of systemic exposure following a single intratympanic injection of AM-101.;Primary end point(s): Changes in tinnitus severity as measured by the TBF-12 and in hearing threshold levels from baseline to day 30.

Secondary Outcome Measures