TACTT3
Research type
Research Study
Full title
Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3 (TACTT3)
IRAS ID
137139
Contact name
James Tysome
Contact email
Sponsor organisation
Auris Medical AG
Eudract number
2012-004099-20
Research summary
Tinnitus is the word used for noises ’heard’ in the ear, ears or in the head in the absence of a corresponding sound. Tinnitus can be described as ringing, whistling, hissing, buzzing, music or humming noise. Quite often it is a symptom of cochlear (inner ear) dysfunction. It may be caused by injury to the cochlear, for example, from exposure to loud noise, disruptions of blood flow to the inner ear or infections.\nCurrently there is no treatment that can cure tinnitus consistently and reliably and there is no common standard of care for severe inner ear tinnitus. While a class of drugs called steroids or medications that seek to improve blood flow to and within the ear are commonly prescribed, their effectiveness is not clearly established. Counselling, tinnitus retraining therapy or psychotherapy are often used to help patients deal with their tinnitus.\nAM-101 is a gel formulation and contains an active substance called Esketamine (0.87 mg/ml) developed for the treatment of tinnitus, which has been in clinical use for many years as an anaesthetic (numbing) and for pain management (painkilling). In clinical trials AM-101 shows significant beneficial effects in the treatment of tinnitus. Furthermore, AM-101 is shown to be safe to use.\nAuris Medical AG is sponsoring this study to obtain further information about the safety and efficacy of a treatment with the study medication AM-101 when administered into the middle ear. Patients suffering from serious tinnitus that started within the last 12 months as a result of an injury to their inner ear or due to middle ear inflammation (otitis media) will be randomly assigned to receive AM-101 (0.87 mg/mL) or placebo in a 3:2 ratio.\nThis is a double-blind study, meaning that neither the participant nor the doctor or the study staff will know, during the entire duration of the study, whether a participant receives AM-101 or placebo. \nThis is a multicentre study which will take place across Europe, approximately 600 patients are expected to take part in this study, approximately 134 screened and 94 randomised of those will be in the UK. \n
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0312
Date of REC Opinion
25 Sep 2013
REC opinion
Favourable Opinion