Inner ear tinnitus MedDRA version: 8.1 Level: LLT Classification code 10043882 Term: Tinnitus
Conditions
Interventions
Product Code: AM-101
Pharmaceutical Form: Gel for injection
INN or Proposed INN: Esketamine hydrochloride
CAS Number: 33643-47-9
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: e
Sponsors
Laboratoires Auris SAS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed