AMPACT2 - An open-label extension to the TACTT3 study
Research type
Research Study
Full title
AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 2 (AMPACT2) – an open-label extension to the TACTT3 study
IRAS ID
129449
Contact name
James Tysome
Contact email
Sponsor organisation
Auris Medical AG
Eudract number
2013-001527-39
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, or humming noise. Quite often, it is a symptom of cochlear (inner ear) dysfunction. It may be caused by injury to the cochlea, for example, from exposure to loud noise, disruptions of blood flow to the inner ear or infections.\nAs of today, there exists neither a universal standard of care for tinnitus, nor a truly proven, effective\ndrug treatment. Hypnosis, psychotherapy, counseling or Tinnitus Retraining Therapy are used to help patients to deal with their tinnitus. Drug treatments that seek to improve the blood flow to and within the inner ear are commonly prescribed, however their effectiveness has not been established.\nAM-101 is a gel formulation and contains an active substance called Esketamine (0.87 mg/ml). Esketamine has been in clinical use for many years as an anaesthetic (numbing) and for pain management (painkilling). The doses that will be used in the studies with AM-101are substantially below the doses known for safe anaesthetic or analgesic use. 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 extension study to obtain information about the safety and efficacy over a longer treatment period with repeated treatment cycles (1, 2 or 3 cycles) with the study medication AM-101.\nThis is an open-label extension study to the previous TACTT3 study meaning that participants will only be receiving the study medication (AM-101). \nAMPACT2 is a multicentre extension to the TACTT 3 study. The study will take place across Europe, approximately 600 patients who have taken part in the TACTT 3 study are expected to take part in this study, 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/0448
Date of REC Opinion
23 Dec 2013
REC opinion
Favourable Opinion