Very good, this still seems absurd though:
"Moderate or severe depression or generalised anxiety" as an exclusion criteria. If I'm depressed I won't notice properly if my T has changed or not?
Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter attheedgeofscience
- Start date
"Moderate or severe depression or generalised anxiety" as an exclusion criteria. If I'm depressed I won't notice properly if my T has changed or not?
MemberDepression can indeed make your perception of Tinnitus worse. I was very depressed in the beginning of this year and I am sure it made me experience Tinnitus a lot worse then it has been for the last nine years. I'm still not out of it and am still taking medication for it but I have seen that as my depression has decreased the annoyance caused by T. has decreased as well. When I measure my T. the amount of sound to mask it is just the same now as it was 6 months ago but I don't hear it as much now as then and it doesn't bother me as much. Even though it still does but not to that extreme extent where I seriously was thinking of offing myself.
So yes depression is a biggie in T.
I don't think the requirements have changed as their FAQ on the Autifony web site still shows the hearing loss requirement. The clinicaltrials.gov web site hasn't changed since May so I think it is still the same. Even if they left out the hearing loss requirement, doesn't mean they are required to take you if you don't have loss.
While we are looking at the trial as a treatment, Autifony is looking at it as an experiment to see if it works. They spent many millions (pounds and dollars) to develop this drug and they set tight guidelines for testing. With such a small sample size they need the tinnitus cases to be as similar as they can get them. If this works and moves onto Phase III, the requirements will probably loosen up to include a broader audience. The one thing to keep in mind is whether it is Phase II or III, these are all experiments that involve placebos. You are a humanized lab rat.
We can hope the trial shows the drug clearly is effective in Phase II, and Phase III ramps up quickly.
While we are looking at the trial as a treatment, Autifony is looking at it as an experiment to see if it works. They spent many millions (pounds and dollars) to develop this drug and they set tight guidelines for testing. With such a small sample size they need the tinnitus cases to be as similar as they can get them. If this works and moves onto Phase III, the requirements will probably loosen up to include a broader audience. The one thing to keep in mind is whether it is Phase II or III, these are all experiments that involve placebos. You are a humanized lab rat.
We can hope the trial shows the drug clearly is effective in Phase II, and Phase III ramps up quickly.
It's all very frustrating - if you're depressed / anxious about your T you can't get on the trial. If you're coping well with your T you can't get on the trial ! I went for screening for the trial but because I'm not 'suffering' enough I was excluded. I do kind of get it but I would definately know if my T improved or the volume decreased . . . hey ho !!! 
I'd bet the clinicaltrials.gov was updated more recently than Autifony's website though.
And if you meet all the requirements and you do not have anything listed in the exclusion criteria they kinda do have to take you in. Otherwise they are just screwing the initial design of the study. Cherrypicking people is not the way to go in clinical trials.
Maybe you should just try again?It's all very frustrating - if you're depressed / anxious about your T you can't get on the trial. If you're coping well with your T you can't get on the trial ! I went for screening for the trial but because I'm not 'suffering' enough I was excluded. I do kind of get it but I would definately know if my T improved or the volume decreased . . . hey ho !!!
Hi nills, I'll wait and see if there's a phase 111 trial and if so what the criteria is for that. It might be that many who haven't been eccepted onto the current trial might well be ok for the next. We'll just have to wait and see.
Yes, they will progress to phase 111 if they achieve what they set out to in phase 11. I've heard we should know this either the end of this year or early next year.
Q2 2016 is the official date range. Why it will take 4 months after they lock the database I don't know. There's no complicated stats to be done. That's the date. Lets keep living and be confident it'll be good news. They are an ethical company who seem to really want to help.
Not only they want to help us but because there are also alot of billions of dollars behind.
but it does not matter they deserve better .
I'll give them all my fortune to kill the fly for ever that lives in my head.
@All Canadian sufferers!
We need to make up a petition to Autifony, asking them to open a Phase III in Canada!
And we have to do it NOW, not later, because later will be too late.
AM 101 has a phase III in Canada, and so should Autifony. Canadian T sufferers should not be left out to dry.
Who is with me?
We need to make up a petition to Autifony, asking them to open a Phase III in Canada!
And we have to do it NOW, not later, because later will be too late.
AM 101 has a phase III in Canada, and so should Autifony. Canadian T sufferers should not be left out to dry.
Who is with me?
Guys don't worry - IF this drug gets to market, it will be available worldwide very quickly irrelevent of where the trials are done. So just hang tight, let's see what the results of the trials are and if it's successful you will have access to the drug at some point. Xx
At some point isnt good enough for me....If phase 3 will be limited to UK/EU/USA, it will mean 1-2 years until phase 4 (market release) for Canadians and Aussies. That is not acceptable, we need to make sure Canada is included like in the AM101 trials.
What is the point is this comment? What is the point of this whole thread which has disintegrated into fruitless comments based on zilch....I totally agree with Nils.....please can we keep this thread for useful and practical knowledgeable posts or nothing at all otherwise this is no more than people gossiping over a garden fence.....
For anyone wondering how Autifony's drug works-
"AUT3, a Kv3.1 positive modulator, suppresses chronic noise-induced tinnitus in a rat model Jeremy G. Turner 1,2, Deb Larsen 1 , Charles Large 3 1 Southern Illinois University School of Medicine, Springfield IL, USA 2 Illinois College, Jacksonville IL USA 3 Autifony Therapeutics Limited, London, UK
Kv3.1 channels are voltage-gated potassium channels that enable fast repolarization of the neuronal action potential, and are essential for the high frequency, high fidelity firing of neurons in the auditory brainstem and midbrain. Altered activity of these neurons has been implicated in the generation of tinnitus induced by noise exposure. Furthermore, loss of Kv3 channel function has been observed shortly after noise exposure, which may contribute to the maladaptive plasticity leading to the emergence of tinnitus. In the current study, 20 Long Evans rats (and 10 sham controls) were exposed to a unilateral 116 dB, 16 kHz octave-band noise for one hour in order to induce temporary hearing loss and chronic tinnitus. Thirty days after the noise exposure, a subset of approximately half of the noiseexposed rats demonstrated deficits in auditory gap processing, consistent with the presence of tinnitus. All 30 rats were administered 30 and 60 mg/kg of AUT3 (a Kv3.1 positive modulator) and vehicle in a counterbalanced order, with 48-hours washout between treatments. Both the 30 and 60 mg/kg doses of AUT3 abolished evidence of tinnitus, while the drug had no effect on the behavior of control animals or noise-exposed animals without tinnitus. These results suggest that AUT3 has potential in the treatment of chronic tinnitus associated with noise-induced hearing loss."
"AUT3, a Kv3.1 positive modulator, suppresses chronic noise-induced tinnitus in a rat model Jeremy G. Turner 1,2, Deb Larsen 1 , Charles Large 3 1 Southern Illinois University School of Medicine, Springfield IL, USA 2 Illinois College, Jacksonville IL USA 3 Autifony Therapeutics Limited, London, UK
Kv3.1 channels are voltage-gated potassium channels that enable fast repolarization of the neuronal action potential, and are essential for the high frequency, high fidelity firing of neurons in the auditory brainstem and midbrain. Altered activity of these neurons has been implicated in the generation of tinnitus induced by noise exposure. Furthermore, loss of Kv3 channel function has been observed shortly after noise exposure, which may contribute to the maladaptive plasticity leading to the emergence of tinnitus. In the current study, 20 Long Evans rats (and 10 sham controls) were exposed to a unilateral 116 dB, 16 kHz octave-band noise for one hour in order to induce temporary hearing loss and chronic tinnitus. Thirty days after the noise exposure, a subset of approximately half of the noiseexposed rats demonstrated deficits in auditory gap processing, consistent with the presence of tinnitus. All 30 rats were administered 30 and 60 mg/kg of AUT3 (a Kv3.1 positive modulator) and vehicle in a counterbalanced order, with 48-hours washout between treatments. Both the 30 and 60 mg/kg doses of AUT3 abolished evidence of tinnitus, while the drug had no effect on the behavior of control animals or noise-exposed animals without tinnitus. These results suggest that AUT3 has potential in the treatment of chronic tinnitus associated with noise-induced hearing loss."
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