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

aboratoires Auris SAS0 个研究点开始时间: 2006年10月24日最近更新: 2012年3月19日

试验速览

暂无简介。

•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

•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

发起方

aboratoires Auris SAS