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Autifony QUIET-1 Phase II Tinnitus Trial Terminated

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Autifony have announced (pdf only) that their AUT00063 Phase II trial for tinnitus has been terminated due to lack of efficacy.

While the Phase I trial showed that the drug was safe and well-tolerated, the Phase II trial failed to show that the drug had any significant treatment effect on tinnitus.

Many people had their hopes set on AUT00063 as the holy grail of tinnitus treatment - quite understandable when you have a debilitating condition like tinnitus. Yet, as long ago as 2013, I did caution against being overly optimistic in my article here.

My reason for caution is that tinnitus is a very heterogeneous condition, that is to say that it is "diverse in character or content". The experience of tinnitus differs from one person to the next, in pitch, in quality, in loudness. Some people experience whooshing, while others experience beeping, ringing, hissing, clicking, ticking, humming, buzzing, shushing and so on. The location of where tinnitus resides in the brain is also very tricky, as "central gain control" in the brainstem and neuroplasticity in the auditory cortex are both indicated, but may play a greater or lesser role from patient to patient. And there is, as yet, no diagnostic procedure to determine where a particular patient's tinnitus is residing in the brain, or which treatment(s), if any, are going to be effective. You just have to try something and see if it works. This takes time and patience, both for the patient, and the Audiologist. 

This study, which I highlighted on our Facebook page, shows that there are many areas of the brain involved in tinnitus generation, and it is therefore a very complex beast to pin down... so targeting a drug at one specific area isn't necessarily going to work for everyone, as the withdrawal of the AUT00063 Phase II tinnitus trial bears out.

However, neuroscientist have indentified a brain mechanism that may be responsible for both tinnitus and chronic pain, as we reported on our facebook page here.

So, it's not all bad news... maybe they'll find a way to reverse the neorplastic changes associated with tinnitus and restore the gatekeeper function that enables the majority of people to acclimatise to their tinnitus?

And for those who are still hanging on for a medical treatment for tinnitus, there's always SF0034, another drug which aims of modulate potassium channels, but with fewer side effects. Note, that they say "fewer" side effects... that's not to say that the treatment will be free of side effects. I expect that many tinnitus sufferers would gladly put up with side effects if it will rid them of their tinnitus. I reported on SF0034 here.

Looking to the future, we may yet see a day when there is a gene therapy that cures hearing loss, and by extension, it may very well cure tinnitus for some patients (as around 75% of tinnitus patients with hearing loss find that wearing hearing aids to correct their hearing also alleviates their tinnitus). We reported a promising gene therapy on our Facebook page here.

I hope people will take this in the spirit in which it is intended. I did get villified for my previous posting about AUT00063, yet my caution was certainly justified. I have always said that I am hopeful that a cure for tinnitus can be found. For the reasons laid out above, I believe that there won't be one single cure that treats every case of tinnitus. There are some promising treatments that may yet bear fruit, as I mentioned just now.

Currently, the Oticon Alta2 Pro Ti and Nera2 Pro Ti are showing great promise for some patients. Some patients are doing very well with the SoundCure Serenade, which is a neuromodulation device that is very effective at suppressing (not masking) tinnitus in around a third of patients, while another neuromodulation device, called mutebutton, is currently available only in Southern Ireland, but is expected imminently in the UK.


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Jason Levy RHAD CTP HPD MNCH (Reg) is an Audiologist, Certified Tinnitus Practitioner, HCPC Registered Hearing Aid Dispenser and CNHC Registered Hypnotherapist. Following a partial loss of hearing since childhood and acquiring tinnitus as an adult, he has been actively involved in treating hearing loss and tinnitus since 2003, and now writes about tinnitus and its treatment. Combining evidence-based Conventional and Complimentary Healthcare techniques, he aims to bring to you a new perspective on tinnitus treatment. In addition to treating tinnitus, Jason is trained in the latest and most up to date digital hearing aids, as well as advanced deep impression techniques for invisible hearing aids such as the Starkey Soundlens.

He practices on Harley Street, and is happy to answer enquiries from prospective clients. Please call 020 3397 9787 to book an appointment.

You can find Jason on Google+Twitter and LinkedInLinkedIn.

London Tinnitus Treatment Clinic Jason Levy HCPC Registered Hearing Aid Dispenser London Tinnitus Treatment Clinic Jason Levy Full Member of the British Society of Audiology
London Tinnitus Treatment Clinic Jason Levy Full Member of the British Academy of Audiology
London Tinnitus Treatment Clinic CNHC Registered Hypnotherapist
London Tinnitus Treatment Clinic Jason Levy Member of the National Council for Hypnotherapy

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